Associate, Quality Control Resume Sample
Gunnar O'Hara
672 Eladio Landing,
Houston,
TX
+1 (555) 653 2809
Work Experience
Senior Associate Quality Control
02/2016
-
PRESENT
Detroit, MI
- QC in-process sample pick-ups
- Transport, dispensing, and distribution to the internal and external QC testing labs
- Timely CoA generation and In-process Data review and approval
- Inventory Management of Retain Material
- Custody and management of stability samples
- Management of the QC stability studies
- Equipment monitoring and response to alarms
- Coordinates/performs testing and review for analytical data to support release/stability of drug substance and drug product and validation activities. Provides troubleshooting support for instruments/complex problems and manages non complex issues, barriers, problems to support team success. Can approve data, reports for team, area of discipline/focus.
Associate, Quality Control
07/2012
-
08/2015
Dallas, TX
- Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Chemistry laboratory. Actively provides leadership and mentoring as needed to aide in the development of team/peers, self and team projects
- Proactively identifies technical gaps and areas for improvement related to quality
- Perform routine laboratory procedures
- Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance
- Prepare complete, accurate, concise laboratory documentation
- Data entry, review, analysis and communication of results
- Maintain/operate specialized equipment
Senior Associate, Quality Control
08/2009
-
02/2012
Dallas, TX
- Participate in the document revision process
- Comply with safety guidelines, cGMPs and other applicable regulatory requirements
- Plan and perform routine analyses with greater efficiency and accuracy
- Prepares sample reconciliation reports and other reports as needed. Creates LIMS system documentation such as SOP’s, Installation and User Manuals and Training Materials
- In depth experience in a laboratory environment with direct experience in bio-analytical techniques and equipment related to the testing of biotechnological products or chemicals and three (3) to six (6) years’ experience with cGMP required
- Experience in method development desired
- Experience in method qualification, method transfer, and method validation required
- Knowledge of compendial requirements
- Knowledge of CFR, USP, and ICH required
Education
University of Wisconsin–Marinette
2004 - 2008
Bachelor's Degree in Biological Science
Professional Skills
- Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively
- Strong communication skills (both written and oral), facilitation and presentation skills
- Problem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scope
- Demonstrated experience in investigations, change control, validation, audits, QC processes Demonstrated ability to interpret scientific literature
- Demonstrated instrument/method troubleshooting skills (HPLC/UPLC, CE, pH, UV-Vis, etc.)
- Strong communications and problem solving skills
- Excellent communication skills in Danish and English
How to write Associate, Quality Control Resume
Associate, Quality Control role is responsible for organizational, troubleshooting, scientific, technical, analytical, events, manufacturing, auditing, supervision, presentation.
To write great resume for associate, quality control job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate, Quality Control Resume
The section contact information is important in your associate, quality control resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate, Quality Control Resume
The section work experience is an essential part of your associate, quality control resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate, quality control responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate, quality control position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate, Quality Control resume experience can include:
- Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data
- Developing instrument/method troubleshooting skills (HPLC/UPLC, CE, pH, UV-Vis, etc.)
- Strong ability to coordinate and prioritise tasks for ensuring department’s time and quality compliance concerning QC activities
- Works on process, on technical writing skills, and authors reports with input & guidance
- Experience in QC laboratory, LIMS administration or equivalent related training and experience
- Technical writing skills within a highly regulated environment
Education on an Associate, Quality Control Resume
Make sure to make education a priority on your associate, quality control resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate, quality control experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate, Quality Control Resume
When listing skills on your associate, quality control resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate, quality control skills:
- Demonstrates good facilitation, organizational and problem solving skills, as well as demonstrated technical expertise
- Demonstrated investigational and problem-solving skills related to nonconforming events
- Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with supervision
- Demonstrated experience in investigations, change control, validation, audits, QC processes
- Self-motivated, strong organizational skills and ability to manage multiple tasks at one time with minimal supervision
- Demonstrated experience in investigations, change control, validation, audits, and QC processes
List of Typical Experience For an Associate, Quality Control Resume
1
Experience For Senior Associate Quality Control Resume
- Good Planning and Organization, Problem Solving skills
- Applies broad-based research, information gathering and analytical skills to factual information
- Write protocols and perform validation and equipment qualification/ verification. Operate and maintain specialised equipment
- Experience required includes operating, maintaining, and troubleshooting sequencing techniques
- Responsible for managing and performing and/or supporting method and equipment qualifications and validations
2
Experience For Associate Quality Control Resume
- Responsible for performing and/or supporting method qualifications/validations
- Hands on experience with Environmental Monitoring, gowning and aseptic technique
- Performs all work in accordance with good manufacturing practice and regulatory criteria, ensures personnel do the same
- Experience using Laboratory Information Management Systems
- Experience using Chromatography Data Systems, such as Empower
- Biopharmaceutical and/or medical technology experience with increasing responsibility in the organization
- Experience with testing in a quality environment
3
Experience For Senior Associate, Quality Control Resume
- Flexible and adaptable to changing priorities and requirements
- Strong Background in Sample Preparation (aliquoting, serial dilutions)
- Work with the Global QC Network on the prioritization of work requests
- 5). Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results
- Experience in performing analytical methods using chromatography
- Experience executing analytical test methods
4
Experience For Senior Associate Quality Control Lims Resume
- Experience in performing cell based analytical methods such as ELISA, bioassay and potency assays
- Experience with Microbiology testing techniques such as Membrane Filtration
- Experience and training in aseptic technique
- Experience from GMP regulated laboratory
- Laboratory experience within bioassays
- Professional work experience in a fast-paced, flexible GxP laboratory
5
Experience For Master Associate, Quality Control Resume
- Demonstrated ability to interpret scientific literature
- Experience with Polymerase Chain Reaction
- Experience with mammalian cell culture and bioassay technology
- Demonstrated in-depth knowledge of laboratory equipment and operations
- Experience in capillary electrophoresis and other compendial methods such as UV, pH, appearance, sub-visible particles and osmolality
- Experience in regulated environment (GLP and/or cGMP)
6
Experience For Senior Associate Quality Control Hplc / CE Resume
- Experience with Material and Data Management
- Experience with electronic Laboratory Information Management Systems
- Experience with Quality Records (Change Control, NCs, CAPA) and GMP Documents (SOPs, Protocols, etc)
- Strong Knowledge of Potency Assays or Cell based assays, Immunoassays, ELISA, Dot Blot, and/or Serology
- Experience in laboratory
- Organize work, handle multiple priorities and meet deadlines
- Experience with mammalian cell culture and bioassay analytical methods
- Experience in Endotoxin, Protein concentration analysis and General Lab
7
Experience For Biologics Associate, Quality Control Resume
- Aseptic technique, aseptic gowning, handling microorganisms, pipette experience
- Supports assay acquisitions, qualifications and validations as well as special projects as assigned
- Demonstrated ability to think and act strategically to support key business decisions
- Operation, maintenance, and troubleshooting experience with Environmental Monitoring equipment and instrumentation
- Professional work experience in a GMP QC Microbiology Lab
- Operation and maintenance experience with laboratory equipment
- Experience with Excel, Word, Assist, and related programs
- Identifying and recommending process improvements while leading implementation efforts
- Assisting with laboratory analysis for commercial release and routine stability testing
8
Experience For Senior Associate, Quality Control Chemistry Resume
- Performs environmental monitoring, routine testing, and reviews analytical data supporting the introduction and release of Biogen products in Brazil. 55%
- Provide supervision and technical support as responsible scientist for bioassays with regard to testing, trouble shooting and method improvement,
- Conduct training for new and existing staff
- Provides technical input for decisions related to complex problem solving while helping to manage non-complex problems routinely
- Receipt of incoming shipments and processing of temperature monitors
9
Experience For Associate Quality Control Reviewer Resume
- Accurately performs analytical and/or microbiological testing following SOPs as needed
- Assists in developing and qualifying analytical and/or microbiological methods with frequent supervision as needed
- Participates in writing and revising SOPs, forms, protocols
- Performs general laboratory support activities including general equipment maintenance and housekeeping
- Significant technical/operational risk due to increasing legal, regulatory and chemical complexity
- Visual / Hearing Demands
- Trend analysis of non-conformances relating to QC
- Apply expertise and critical thinking to independently resolve issues
- Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP
10
Experience For Associate, Quality Control Sample Management Resume
- Coordinate/perform testing and review of analytical data to support timely release of drug substance and drug product and stability samples
- Ensure all testing performed in compliance with cGMP
- Provide troubleshooting support for analytical instruments where needed
- Provide technical support during audits/inspections
- Generate complete, accurate, and concise documentation using electronic systems and laboratory notebooks
List of Typical Skills For an Associate, Quality Control Resume
1
Skills For Senior Associate Quality Control Resume
- Strong skills in manual and/or electronic micropipettes use
- Strong communication skills and the ability to collaborate across multiple functional areas of the organization
- Excellent organizational skills and a superior attention to detail
- Strong analytical skills with ability to translate sometimes ambiguous data sets into actionable insights and recommendations
- Be self-motivated, able to interface effectively with various levels, and able to prioritize to meet deadlines
- Excellent organizational skills and a great attention to detail
2
Skills For Associate Quality Control Resume
- Self-motivated, able to interface effectively with various levels, and able to prioritize to meet deadlines
- Participates effectively in membership role for site cross-functional teams as a representative of the laboratory
- PhD in Biotechnology, or related field, with no prior experience; or
- Exceptional organizational skills, attention to detail, and sense of urgency required
- M.S./M.A. in Biotechnology, or related field, with no prior experience; or
- Demonstrated experience with various laboratory practices
- Experience in biotechnology or a related industry with a track record of strong scientific contributions and project leadership
3
Skills For Senior Associate, Quality Control Resume
- Experience in regulated laboratory environment and demonstrated laboratory technique
- Able to identify and explore alternative solutions and effectively weigh the elements that are critical to product quality, safety and compliance
- Microbiology experience or quality lab experience
- Fully bilingual communications skills (English and Spanish)
- Identify roadblocks to task completion and effectively brings them to line managers for resolution
- Understanding of scientific principle, ability to communicate with peers and management; GMP/GDP experience
- Working knowledge and experience in adherent cell culture
4
Skills For Senior Associate Quality Control Lims Resume
- Assists in developing and qualifying/validating analytical methods with frequent supervision
- Assists in developing and qualifying/validating analytical methods as necessary
- A good understanding of working with pharmakopeias (EP, USP, JP, JPE, ACS)
- Demonstrate understanding of regulatory requirements, safety guidelines and factors impacting compliance
- A good understanding of GMP/GLP guidelines
- Demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology
- Biopharmaceutical and/or medical technology experience with increasing responsibility in the organization
- Demonstrates understanding of when and how to appropriately escalate
- Experience in advance data trending and evaluation
5
Skills For Master Associate, Quality Control Resume
- Experience using various IT systems
- Process in process, validation, release, and other related samples for QC testing with in LIMS
- Ensure effective and robust processes for sample documentation filing, archival and retrieval
- Participates in the validation of plant systems and manufacturing processes
- Good commence in English and Bahasa Malaysia
- Set deadlines and prioritize work for self, group members and support groups involved
- MS in Biotechnology, or related field with no previous industry laboratory experience
- B.S/B.A. in Biotechnology, or related field with at least 1 to 3 years experience in a laboratory environment
- B.S./B.A. in Biotechnology, or related field with no previous industry laboratory experience
6
Skills For Senior Associate Quality Control Hplc / CE Resume
- B.S./B.A. in Biotechnology, or related field with no previous industry laboratory experience; or
- B.S/B.A. in Biotechnology, or related field with at least 1 to 3 years’ experience in a laboratory environment
- Experience as a laboratory technician or equivalent position
- Communicate with peers and management; GMP/GDP experience
- Writes protocols and executes microbiological method validations
- Experience with LIMS SM
- Experience in LMES and SmartLab Method Builder
- Experience with CIMS, LIMS, and/or Empower
7
Skills For Biologics Associate, Quality Control Resume
- Experience in Quality Systems- QMTS
- Experience with Sample Manager LIMS
- Experience with Maximo and familiarity with lab equipment
- Pharmaceutical and/or Biotech work experience
- Laboratory experience in a GMP environment
8
Skills For Senior Associate, Quality Control Chemistry Resume
- Relate day-to-day work to business priorities
- Author investigational protocols, investigational reports, change control requests, validation/qualification protocols and reports
- Lifting, carrying, pushing or pulling up to 50 pounds occasionally
- Initiating and owning class 1 non-conformances in Trackwise
- Templating in LIMS, Empower, and/or Tecan templating to support the MDG team and the Global QC network
9
Skills For Associate Quality Control Reviewer Resume
- Understanding and application of principles, concepts, theories and standards of technical/scientific field
- Understanding of basic scientific principle
- Writing and use of a computer keyboard frequently
- Understanding of when and how to appropriately escalate
- Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing,
- Frequent periods of sitting, walking, and standing
- Occasional low level work, fine finger dexterity/ including grasping or pinching required
10
Skills For Associate, Quality Control Sample Management Resume
- Respond during and after hours to temperature chamber alarms while providing on call support during shutdowns as needed
- Water labeling, receiving, and logging
- Performs routine raw material and analytical chemistry testing including HPLC, UPLC, UV, CE
- Accurately performs analytical testing following SOPs
- Accurately performs analytical testing such as HPLC, SDS-PAGE, ELISA, CE-SDS, and cIEF following SOPs
- Assists in developing and qualifying analytical methods with frequent supervision
List of Typical Responsibilities For an Associate, Quality Control Resume
1
Responsibilities For Senior Associate Quality Control Resume
- Provides technical leadership through effective project management including laboratory investigations, technical problem solving with independence
- Operate and maintain specialized laboratory equipment and instrumentation
- Tracking equipment inventory and purging inactive equipment
- Maintaining inventory lists and associated documents
- Perform analytical testing in accordance with established Analytical Methods and Standard Operating Procedures
2
Responsibilities For Associate Quality Control Resume
- Procurement of materials and equipment using the MyBuy purchasing tool
- Contribute to, oversee, run and participate in root cause analysis, implementing improvements and corrective actions
- Respond to Critical Equipment Monitoring System alarms
- Execute routine and non-routine testing procedures and assays
- Maintain testing equipment at a high level to quality to ensure accuracy and consistency of test results
- Perform data analysis of testing results and communicate results to appropriate sources
3
Responsibilities For Senior Associate, Quality Control Resume
- General understanding of industry practice and standards
- Establish approaches for completing assignments
- Prepare outgoing shipments for both domestic and international destinations
- Contributes to work group/team by ensuring the quality of the tasks/services provided by self
- Provides training/guidance to others and acts as a technical/scientific resource within work group/team
4
Responsibilities For Senior Associate Quality Control Lims Resume
- Comply with gowning and hygiene requirements defined for specific job role
- Line-activities according to Quality Activity Plans (QAPs)
- The QC sample Control group supports manufacturing and QC operations 7 days a week.
- Proactively contribute to solving GS customer’s needs
- Knowledge on Automation systems like liquid Handling systems and Cell counters
- Advance data trending and evaluation
5
Responsibilities For Master Associate, Quality Control Resume
- Evaluate documentation/data according to company and regulatory guidelines
- General understanding of Amgen products and Quality Control operations
- Fluent in English and Spanish languages (oral and writing)
- Available to support non-standard shift (including 1st, 2nd, 3rd and weekends shifts)
- Knowledge of Trackwise, LIMS, and Waters Empower Chromatography Data System desired
- Develop and manage budget plans and forecasts
- Highly regulated (FDA, DEA, EMEA, Virginia DEQ, EPA) work environment
- Occasional use of personal protective equipment
- Color vision and depth perception required
6
Responsibilities For Senior Associate Quality Control Hplc / CE Resume
- Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels
- Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals
- Demonstrates strong attention to detail, and an ability to focus on details of execution
- Expertise is required in one of the following areas: Raw Material testing, Compendial methods, TOC analysis, Conductivity, or physico-chemical testing. The required expertise is with respect to demonstrating theoretical understanding and providing effective analytical troubleshooting
- Knowledge of LIMS, ELISA software (i.e., Softmax Pro) and luminometer is required. Ability to implement and demonstrate testing in accordance 21CFR11 is required
7
Responsibilities For Biologics Associate, Quality Control Resume
- Reviewing and approving product CoA’s and In process Result Summary Reports
- Through GCC and activity execution; where necessary. Contributes to overall RAR’s, work order, PM’s, system optimization efforts, projects
- Participates in the execution of method transfer, method development, method qualification, analytical improvement projects, control qualification, and validation of analytical methods in collaboration with teams as appropriate
- Support QC’s global change control processes as a subject matter expert with respect to specification and method changes due to the implementation of new raw material methods and technologies
- Report writing for investigations
- All activities within Amgen’s quality system associated with the QC nonconformance investigations, CAPA records and Analytical Results Assessments
- Ensure investigations constantly reflect current requirements and expectations
- Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings
- Lead continuous improvement activities to achieve standards of operational excellence for Amgen
8
Responsibilities For Senior Associate, Quality Control Chemistry Resume
- Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals
- Ensure timely completion of Quality Control Non Conformances, Investigations, CAPAs through the Non Conformance procedures
- Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s)
- Ensure flow of communication to stakeholders
- Be responsible for specific programs and/or projects
- Develop training documentation and SOP’s for laboratory LIMS/ LMES/ CIMS requirements in adherence to Amgen requirements, SOP’s, Standards, GAMP5, Annex 11, PIC/s and 21 CFR part 11 for all laboratory systems
- Ensures the system’s application user operations procedures are accurate, effective and being followed for the application, user responsibilities, user roles, access privileges and training requirements per role
- Participate in the generation and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
- Ph.D, 5+ years M.S. and 7+ years B.S. in comparable role with GMP experience and role with leadership aptitude and strong analytical skills
9
Responsibilities For Associate Quality Control Reviewer Resume
- Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Bioassay laboratory
- Strong knowledge of GMP, GDP, SOPs and quality control processes
- Support validation, transfer and/or qualification activities by review of protocols and reports
- Lift 25 lbs and work with dry ice and LN2 freezers
- Author of quality documents such as deviations, change control requests and CAPAs to ensure compliant with cGMP
- Proactively identify technical gaps and areas for improvement related to quality and lead them through completion
- Supports QC Biochemistry operations related to business and manufacturing schedules; Participates effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Biochemistry laboratory related to laboratory improvements and projects
- Create and review methods and procedures for completeness and accuracy
10
Responsibilities For Associate, Quality Control Sample Management Resume
- Learn and comply with GLP, and cGMPs, which includes, but is not limited to, the maintenance of training records, laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books
- Learn and comply with GLP, and cGMPs, which includes, but is not limited to, the maintenance of laboratory notebooks, written procedures, equipment monitoring systems and laboratory log books
- Participates in the execution of method transfer, method development, method optimization, method validation in collaboration with teams as appropriate
- Performs in-process cGMP testing, cell culture and molecular-based
- Supports maintenance of laboratory systems to ensure integrity of all laboratory results
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