QC Coordinator Resume Sample
Liza Schaden
77218 Hirthe Fall,
San Francisco,
CA
+1 (555) 897 7514
Work Experience
QC Coordinator
04/2017
-
PRESENT
New York, NY
- Basic fit trial assistance - Required to help support Commercialization Coordinator document, analyze and communicate results of fit-trials to Quality Department and Product Development Departments as needed
- Field test trial assistance - Required to help support Commercialization Coordinator to document, analyze and communicate results of field test trials to Quality Department and Product Development Departments as needed
- Travel, domestic and overseas, approximately 10% of time
- Communicate effectively across many departments, many cultures and with foreign factories
- Track multiple projects and manage multiple tasks simultaneously
- To ensure all test fabric orders are completed and prepared for despatch, in accordance with quality protocols and standards; and in accordance with the customer’s specified delivery date
- To ensure that there is a commitment to the principle of continual quality improvement, with the aim to achieve zero non-compliance of quality standards; developing standards and practices as required, and ensuring staff are trained accordingly
- To co-ordinate all activities within the Quality Control Area, to ensure adequate operating levels and resource requirements are maintained at all times to enable production targets to be met
- To provide technical support for Warwick Equest developmental studies when the need arises. The role involves the developing action plans, performing performance studies to evaluate any new/prototype materials and preparing internal reports to summarise results
Caps QC Coordinator
01/2015
-
03/2017
Philadelphia, PA
- The role reports to the Assistant Production Manager
- Set up electronic files for the auditors
- Complete full re-verification process in a timely manner, not to exceed 60 days from the audit selection
- Create re-verification letters based on the post-closing quality control selection of credit documents
- Ensure that all addresses for re-verification letters are correct, and documentation is for the correct borrower
- Assist re-verifying routine audit selections, including early payment default selections
- Precisely and accurately update all re-verification responses, and resend if applicable
- Adequately communicate findings to other team members if necessary
- Research file to determine best documents to be re-verified, and verify contact information
Laboratory QC Coordinator
01/2012
-
10/2014
New York, NY
- Present errors and questions to manager for clarification if needed
- Order and place pre-determined documentation in the electronic files for the Quality Analysts to use in their review process
- Clerical support of any type including but not limited to copying, scanning and mailing
- Reach, grasps, stoop, pull and perform repetitive motion procedures
- Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise
- Processes QA/QC testing samples
- Processes QA/QC inspection packages, including/not limited to R-1’s, travelers, material certs & welder logs
Education
University of Phoenix - Virginia Beach Learning Center
2008 - 2012
Bachelor's Degree in Human Services
Professional Skills
- Strong communication skills, including all levels of the organization and customer base
- Good omputer skills and working experience with common measurement equipment
- Strong problem solving, mathematical, computer, statistics, MS Office , technical, equipment and trade skills
- Strong problem solving, mathematical, computer, statistics, MS Office, technical, equipment and trade skills
- Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities
- Document processes using Lean Six Sigma methodology and other Project Management skills
- Good organizational skills and detail orientation
How to write QC Coordinator Resume
QC Coordinator role is responsible for equipment, basic, credit, training, database, reporting, manufacturing, research, travel, compliance.
To write great resume for qc coordinator job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For QC Coordinator Resume
The section contact information is important in your qc coordinator 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 QC Coordinator Resume
The section work experience is an essential part of your qc coordinator 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 qc coordinator responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular qc coordinator position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative QC Coordinator resume experience can include:
- Responsible for the prioritising of work, and to allocate tasks accordingly
- Knowledgeable of GMP regulations for solid dose, tablet capsule testing for release
- Schedule and prioritize workload of staff to ensure documents are reviewed and testing is performed in a timely manner
- Work on resolving complex problems which requires extensive experience
- Performs Process Audits to validate conformance to existing standards and conduct quarterly work instruction audits
- Interview, select, train and evaluate performance of new hires to staff the department with motivated and skilled professionals
Education on a QC Coordinator Resume
Make sure to make education a priority on your qc coordinator resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your qc coordinator 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 QC Coordinator Resume
When listing skills on your qc coordinator 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 qc coordinator skills:
- Support validation (preparation and approval of validation procedures and reports)
- Experience in quality assurance/shipping/receiving
- Determine priorities of release testing, stability testing, and review submitted
- Process in-coming mail; open, stamp, and sort for priorities. Distribute and/or handle items not requiring
- GC, technical writing, and investigation experience is REQUIRED
- Experience in GMP quality control and/or pharmaceutical manufacturing facility
List of Typical Experience For a QC Coordinator Resume
1
Experience For QC Stability Coordinator Resume
- Maintain filing systems including but not limited to welder certifications & welding procedures
- Maintain schedule of stability pulls, testing deadlines, and reporting deadlines
- Accurately execute transactions in Eagle and QAD to ensure proper closing and labor reporting on all work orders
- Coordinate outside contract testing
- Prepare necessary inspection or QC records as per Documentation & Final Inspection check sheet and compile for issuing to customer
- Complete on-site and off-site training in areas applicable to job performance
- Type variety of documents
- Maintain integrity of Certification Stamps (R, U, etc.)
- Communicate with Authorized Inspectors
2
Experience For Caps QC Coordinator Resume
- Conduct case file and record reviews for compliance and identifies opportunities for improvement or corrective actions and to ensure contractual performance expectations are met
- Ensure 100% of clients participate in the client satisfaction survey
- Review quality assurance standards, study existing policies and procedures and interviews personnel and patients to evaluate effectiveness of quality assurance programs
- Responsible for the management of the staff in the QC area (day to day supervision)
- Responsible for coordination of the QC department in conjunction with production requirements
- Responsible for the monthly stock take
- Providing status updates to other departments regarding the submission of samples (R&D, consumer complaints, extended expiration date samples and stability (sample handling and control, data entry, etc)
- Assigning work load to QC Analyst according to the type of incoming samples on a daily basis
3
Experience For Coordinator, QC Resume
- Able to read and understand Chemistry, micro-biology terminology and documentation
- Create, review, and approve batch specific stability study protocols and summary report tables
- Determine stability sample requirements, develop stability protocols and oversee execution of stability protocols
- Calculate sample quantities required for testing by reviewing the applicable test methods, and calculate number of samples required per study based on pack types and storage conditions
- Assign stability study identification numbers and stability sample quantities/storage condition for batch records that include procedures for stability sampling
- Review specification changes for product, API, and packaging components to assess impact to Regulatory Stability Protocols and revise protocols as needed using appropriate change management systems
- Dispose of samples when study is completed or discontinued
- Participate in stability improvement projects
- Ensure samples are labeled properly and distribute to appropriate stability chamber(s) for storage
4
Experience For Laboratory QC Coordinator Resume
- Monitor stability chambers and chart recorders on a daily basis to confirm environmental conditions for acceptance with established specifications
- Notify and coordinate with Metrologists /Maintenance in the event of an issue with stability chamber performance
- Prepare stability data graphs to estimate expiration dates and verify product shelf life
- Evaluate stability trends and prepare reports
- Initiate action reports or deviation reports for any applicable nonconformance
- Provide a quality review process for data generated in the stability group
- Material / Product Release
- Stability sample management, including logging in of new samples, storing samples in environment chambers and/or stability room, coordinate monthly sample pull for testing and distribution of samples amongst the Quality Control Laboratory network, disposing samples when stability testing is completed
5
Experience For QC Laboratory Operations Coordinator Resume
- Initiating new stability studies utilizing the SLIM application, including reviewing study test forms (LWRs) for trending of results, and completenessm, identifying OOS/OOT test results and subsequent investigation follow up, entering, verifying, and approving study test forms (LWRs)
- Generating Stability Reports upon request for Domestic Brand Requirements, International Registrations, Internal and External Audits, and Product Development, R&D, and Technical Services
- Read and understand chemistry, microbiology terminology and documentation
- Familiar with GMP regulations for dietary supplements
- Physical ability to repetitively lift, stand, climb, bend, etc
- Coordinate with Shop QC inspector & workshop Foremen for the completion of all planned QC/Inspection/Test programs
- Prepare necessary QC/Inspection/Test reports for the activities needed for the job orders executed in the workshop
- Coordinate final inspection and be responsible for the release of workshop job orders after ensuring all activities are complete as per the job record card and Documentation & Final Inspection check sheet
- Oversee the shop job record cards (route cards) are signed-off by the concerned workman upon completion of each activity and follow up with the workshop foreman
6
Experience For QC Fabrication Coordinator Resume
- Ensure that the Documentation/Certification package with correct records reaches the customer along with the delivery of workshop job orders executed
- Coordinate the completion of sub-vendor’s NDE activities and review the NDT reports
- Perform weld visual inspection and other inspection activities at the shop whenever necessary
- Update HSEQ Manager on the Statistic of workshop jobs delivered without QC Records on monthly basis thru’ documented logs
- Preform all necessary activities to achieve Quality objectives set the HSEQ Dept
- Compilation of Documentation/ Certification packages for completed job orders
- Monthly statistics on compilation of QC records for workshop jobs
- Receive and process product returns
- Minimize inspection labor costs by organizing inspection flow, maintaining written procedures that are clear and accurate, and sustain resources required to complete work
7
Experience For Qc Coordinator Physico Chemistry Resume
- Review inspection records to verify they are complete and accurate
- Receive and manage product related to a field action
- Identify and implement improvements to processes in assigned area
- Review analytical results from internal and external testing labs for compliance to specifications and reports abnormalities. Resolve any testing or documentation issues with contract testing labs. Evaluate the stability data for trends
- Manage stability samples inventory, reference standards, and retains. Manage the distribution of stability samples for testing. Coordinate outside contract testing as needed
- Investigate and generate reports on deviations and any non-conformance in accordance with QC procedure
8
Experience For VOD QC Coordinator Resume
- Determine stability sample requirements, develop and review stability protocols in accordance with ICH and regulatory requirements
- Monitor and review control charts of the stability chambers to confirm environmental conditions operating within acceptance tolerances. Collaborate with Validation, QA and other functional SMEs to qualify equipment used to support stability including controlled temperature units and stability software
- Support QC laboratory, as needed. General laboratory support, including but not limited to, sample receipt, inventory control, reagent preparation and equipment and instrument maintenance
- Strong knowledge of bio-analytical techniques for proteins and other biologic products
- Knowledge of ICH Q1A-F and Q5C guidance documents
9
Experience For Produce QC Coordinator Resume
- Able to read and understand Chemistry, microbiology terminology and documentation
- Participate in Director of Pharmacy’s staff meetings
- Manage the establishment and maintainance of an operational QC unit in full cGMP-compliance, i.e. In-Process Control labs, Phys/Chem Release labs, Bioanalytical test labs, and manage review of QC test documents to ensure completeness and accuracy
- Monitoring and optimization of work flows and methods/procedures, inprocess control, release (DS) and stability (DS) pursue an ongoing quality assurance program
- Ensure qualified status of lab equipment and methods for intended use in QC laboratories
- Prepare and participate to health authorities inspections and internal audits in his area
- Manage that all laboratories are operation at the same GMP standards
10
Experience For Field QC Coordinator Resume
- Create, implement, and support production tracking and trending systems and programs which assist in the testing, evaluation, and monitoring of production quality
- Review QA/QC documents to ensure completeness, accuracy, consistency, and clarity and that materials or final products have been manufactured, tested, or inspected according to specification and cGMPs
- Mange that test procedures and new assays are validated
- Optimize test procedures to improve efficiency whenever possible
- Provides technical assistance to various departments
List of Typical Skills For a QC Coordinator Resume
1
Skills For QC Stability Coordinator Resume
- Validation of new reagents and participation to the validation of analytical methods
- QC Inspection of incoming materials, work in process, or finished goods as needed
- Procure validation and qualification support, support launches of manufacturing products
- Several years experience in a cGMP laboratory environment
- Four years of relevant experience required
- Authors stability protocols and obtains necessary approvals prior to study initiation
- Experience in chemical, microbiology or related field
- Creates methods development and validation reports for proper traceability purposes and compliance with regulatory requirements
2
Skills For Caps QC Coordinator Resume
- Creating reports including but not limited to quality data trending, informational spreadsheets, laboratory log spreadsheets, stability spreadsheets, etc
- Understanding and handling of hazardous materials and waste using proper and safe techniques
- Assigning workload to QC Analyst according to the type of incoming samples on a daily basis
- Creating reports including, but not limited to, quality data trending, informational spreadsheets, laboratory log spreadsheets, stability spreadsheets, etc
- Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another and possibly up and down stairs as required
3
Skills For Coordinator, QC Resume
- Providing status updates to other departments regarding the submission of samples
- Assists with processing ISO documentation, training and audits; while ensuring proper documentation of associate training
- Provide daily and weekly updates to Management regarding the status of samples undergoing testing in QC
- Provide input to QC manager regarding equipment, processes, inspection environment, and other related information for inspection planning and scheduling
- Updates and maintains Training Matrix and Training Board to ensure cross-training levels are reported accurately to management
- Administrative support - as needed including, but not limited to, filing and word
- Removes samples from chambers according to protocol pull schedules and submits to appropriate testing group
- Prepares samples for inclusion in stability studies (aliquotting, labeling, distribution to appropriate stability chamber)
4
Skills For Laboratory QC Coordinator Resume
- Responsible for alerting production management of any issues with completed work and help to investigate any complaints arising
- Responsible for developing action plans and performing performance studies to evaluate any new / prototype materials
- Responsible for following health & safety procedures at all times while working for Warwick Equest Ltd
- Support supervisors gathering information, submitting SCARS and Change Controls for required specification changes
- Assist with the filing and archiving of stability studies
- Support supervisors gathering information, submitting Supplier Corrective Action Request (SCARS) and Change Controls for required specification changes
- Prepares new and revises existing standard operating procedures to ensure compliance
5
Skills For QC Laboratory Operations Coordinator Resume
- Ensure all clients receive a return call within 24 hours of calling and leaving a message
- All Microsoft Office products, including PowerPoint, Excel, Word, and ability to learn Access database
- Travel in the U.S. and internationally to project locations with area stays averaging one to three years in length
- Work Environment: Working in a climate controlled office environment
- Co-ordination and tracking of all fabrication contracts associated with the project
6
Skills For QC Fabrication Coordinator Resume
- Responsible for ensuring all completed orders are quality inspected and defective products are rejected
- Responsible for ensuring all relevant paperwork is completed accurately and in a timely manner
- Responsible for stock control and ordering of consumables used in the QC area
- Responsible for ensuring any work instructions / methods used in the QC area are documented and kept up to date and current at all times
- Responsible for preparing internal reports to summarise results
- Responsible for reporting any defective equipment within the QC area
- Responsible for training new operatives in the QC area
- Responsible for following all standard procedures / work instructions at all times
7
Skills For Qc Coordinator Physico Chemistry Resume
- Review and update the MRB and other departments of pending laboratory investigation
- Inspect and release capital equipment products, maintaining individual inspection records for each serial number
- Train assigned inspectors and other employees working within assigned area and monitor workmanship
- Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary
- Oversee the vaccine stability program for Agenus including protocol and report generation for drug substance, drug product shelf life and other special studies
- Review and update the Material Review Board (MRB) and other departments of pending laboratory investigation
- Manage in putting in place quality systems for QC for the plant in accordance with regulations and global guidelines
- Manage that training is performed and documented for all QC personnel and activities
- Recommend investigation of questionable testing results
8
Skills For VOD QC Coordinator Resume
- Take and transcribe meeting minutes and other dictation. Photo-copy documents as required
- Creates, implements and monitors standard operating procedures
- Immediate sense of urgency and follow through are critical elements of this role
- Internet Explorer and other search engines to research information and compile data for use by supervisor and/or management
- Generate, pull or create reports
9
Skills For Produce QC Coordinator Resume
- 1300 TEASLEY LN , DENTON, TX 76205-7946 USA
- Work in a fast pace work environment that requires the ability to multi-task and work under pressure with deadlines
- Perceiving the nature of sounds at normal speaking levels or without correction. Ability to receive detailed information through oral communication, and make fine discriminations in sound
- Conduct inspections in a construction environment (ex. tight or elevated spaces)
- Travel in the U.S. and internationally (25-50%)
- Extensive knowledge of the fabrication process, its implementation and management. Fully conversant with project management tools
- Train employees in their area of responsibility
10
Skills For Field QC Coordinator Resume
- Theorical and practical knowledge of Biochemisty and Physicochemistry testings (HPLC / DIONEX / Colorimetric assay / Karl Fisher / AAS )
- Theorical knowledge of GMP (pratical knowledge is an asset)
- Coordinates with other departments to identify material to be put on stability
- Provides stability data necessary for the submission of various regulatory documents
- Provides stability data to other departments upon request
- To ensure that all project / company HSE goals are achieved and where possible exceeded
- Co-ordination of the compilation of the certification packages for fabrications associated with the project
- Data analysis and compilation of project management reports
List of Typical Responsibilities For a QC Coordinator Resume
1
Responsibilities For QC Stability Coordinator Resume
- Trains QA/QC analysts on new methods and instrumentation
- Insure that all analysts are trained and qualified to perform the assays under cGMPs
- Trains QA technical reviewers on review methods and procedures
- Prepares or assists in the preparation and review of lot protocols for FDA submission
- Able to work in a team and cross functionally
- Assure that the Field Construction Staff is monitoring the execution of work in accordance to the quality standard requested by Project Execution Plan and Site Quality Control (Job Spec.)
2
Responsibilities For Caps QC Coordinator Resume
- Verify that prescribed standard of quality control is maintained, including, but not limited to, the following with Field Project Engineer & Supervisors: the availability at site and the issue to Subcontractors staff of last revision of "approved for construction" drawings, job specifications, purchase orders and material requisitions
- With welding inspector: the issue and updating of Subcontractors Welding Book, the qualification and approval of welding procedures, the validity of welders' test certificates, the maintenance of welding records as per procedure
- Assure that all Quality Control procedures and other field procedures included in Construction Quality Control Plan are kept updated to Client and to Subcontractors
- Coordinate the T/O activities for the definition of the format, the content and filing of the "hand over dossiers"
- Ensure that the tests, controls and inspections are carried out and documented in accordance with the Site Quality Control Plan Ensure that QC certificates as per latest and approved Site Quality Control Plan are received from field supervisors and filed in the proper "Hand Over dossier"
- Extensive track record managing QC Construction activities within Pharma sector
- German language is mandatory
3
Responsibilities For Coordinator, QC Resume
- Release of commercial lots
- Follow-up of the quality system used in the laboratory, deviation management, trend and reagents follow-up …
- Critical review of analytical data
- Process customer complaints and internal quality events to ensure proper resolution of the issue is documented and communicated to all parties involved
- Initiate, review and verify corrective and preventive action plans for completeness
- Verify and maintain the Continuous Improvement activities and work with supervisors and management to ensure plans reduce the chance of reoccurrence of process failures
- Prepare and distribute weekly and monthly metrics or as requested; maintaining the KLS bulletin boards and metrics and key measurable timely
4
Responsibilities For Laboratory QC Coordinator Resume
- Responsible for updating, tracking and maintaining changes to processes, procedures, or documentation and ensuring all customer controlled documents are uploaded for use by the associates
- Assists in periodic physical inventories
- Prepare information and post throughout the warehouse as needed or required
- Equipment Used: Computer
- Maintaining all original documentation related to Stability Program, including creating study folders for each new sample received, generating test forms (LWRs) for monthly sample pull, filing all original test forms (LWRs) and any associated documentation in study folders, trans filing of all completed study folders in accordance with the company’s document retention SOP
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