A QC Associate is a quality control associate who is involved in the process of checking and inspecting products to ensure quality consistency or standards. The job description and duties are listed on the QC Associate Resume as – checking to see if the products are dictated by certain parameters; providing quality control on products in compliance with all necessary regulations, developing quality control systems, data review, and entry and general lab support; revising quality plans and procedures, investigating and recommending corrective action for quality control problems, and assisting in quality control training.
To apply for this role, the applicant must possess a bachelor’s degree in business or science and prior work experience. Other required skills are working knowledge of FDA and state/federal regulations, and analytical skills, and written communication skills.
Summary : Aspiring Environmental Specialist with 8 years QC experience in Manufacturing and Microbiological lab experience. Extensive experience in Sanitation Validation including environmental and equipment inspection.
Skills : Inventory Management, Data Entry, Data Analysis, Filemaker Pro, GMP, Quality Control, Microsoft Office Suite.
Description :
Responsible for performing periodic checks on Production lines and batching silos.
Performed Microbiological and other qualitative tests on work in progress and finished products.
Responsible for the pre-operational sanitation verification.
Responsible for pre-operational QA duties prior to manufacturing start-up.
Examined and validated the sanitation of all critical food contact surfaces.
Obtained additional equipment and environmental swabs to validate the sanitation of peripheral areas.
Maintained a record of sanitation validation.
Experience
7-10 Years
Level
Management
Education
BS In Biochemistry
QC Associate Resume
Objective : Seeks to obtain a position in the pharmaceutical industry where my knowledge, abilities, and experiences could be a contribution to the mission and vision of the institution.
Performed assigned tasks related to laboratory inventory management.
Performed raw material testing and verification.
Analytical method development and validation of methods for in-process and finished products.
Performed QC testing of tablets, capsules, and liquid orals.
Determination of assay and quality control testing of solid orals using dissolution apparatus I and P.
Performed calibration, Preventive Maintenance (PM), and Qualification of HPLC.
Performed calibration of pH meter and UV-VIS spectrophotometer.
Experience
2-5 Years
Level
Junior
Education
MS In Pharmacy
QC Associate Resume
Summary : Creative problem solver spearheads complex research and data analysis of clinical research projects. Consistently executes critical tasks within aggressive timeframes and budgets. Strong communication skills with the ability to foster and maintain professional working relationships within all levels of an organization.
Skills : Team Building, Technology, and Communication, Organizational Ability, Written Expression, Time Management, Technical Oversight, Problem-Solving, and Planning.
Description :
Transferred to QC inventory which included cycle counts that were generated by the previous day's shipments.
Required data entry into a computer.
Worked in all types of environments from the freezer to the no air warehouse.
Worked in a timely fashion, could work alone or in the group, was able to help lock down the spinach when it came on recall.
Used riding pallet jack, cherry picker, headset, scanner, data entry, the tenacity to find missing product, or as to why it was missing.
Ensured visual accuracy of parts.
Wrote suspect material for review by the Material Review Board.
Experience
10+ Years
Level
Senior
Education
GED
QC Associate Resume
Summary : Highly focused experienced Analytical Chemist with a strong background in biotechnology environment; Seeking graduate training in regulatory science to prepare for a challenging further career in the pharma, biotech, or medical device industry.
Designed and implemented a quality management system including design history file, document control, and manufacturing process control.
Collated and maintained required files and documents which supported a medical device pivotal clinical study Collated and maintained files and documents which supported a regulatory submission.
Served as point of contact for internal quality system audit activities.
Served as Management Representative responsible for monitoring and reporting status and effectiveness of the quality system to senior management.
In cooperated with other functional managers create, review and approve QS documents to ensure compliance with QSR, ISO, and other regulatory requirements.
Provided training on these systems/procedures.
Initiated corrective and preventive action plans and participate in corrective actions completion by performing root cause analysis and verifying effectiveness.
Experience
7-10 Years
Level
Management
Education
Certified Nursing Assistant
QC Associate Resume
Objective : QC Associate with 3+ years of experience in Ensuring traceability for major rotating parts as well as the accurate recording of serial numbers for International shipments,Inspecting material in receiving inspection, validation, and recording of accurate part information in SAP.
Quality checked on all statistical output delivered to the client.
QC of Medical Reports, Statistical Analysis Plans, and Clinical Study Reports.
Expert QC review on Study Reports, Protocols, CRF's, Analysis Plans, Tables, Listings, and Figures.
Used SAS and Oracle/Clinical for data verification.
Programmed listing shells using SAS Macros, audited Oracle databases.
Performed edit checks for Data Management.
Experience
2-5 Years
Level
Junior
Education
B. A.
QC Associate Resume
Objective : Seeking to utilize experience and talents in a fast-paced environment in the consumer, pharmaceutical, or medical device industry.
Skills : CESDS, Quality Control, UV/VIS Spectrophotometry, PCR, SDS-PAGE, Western Blotting, Titrimetry, Aseptic Technique, Staining, Serial dilution, Plate streaking, Enumeration Through Viable Plate Count, Large Scale Column Chromatography, Sampling, OD meter, Cleanroom Technology, Buffer Prep.
Description :
Performed QC testing on raw materials, components, and final product release.
Checked and verification of QC data.
Prepared reagents, aliquots, and patient samples.
Instrument maintenance and troubleshooting.
Knowledged of GLPs, GMPs, and QC protocols.
Performed cleaning verification of the instruments.
Performed real-time documentation of the experiments following cGMP guidelines.
Experience
2-5 Years
Level
Junior
Education
B.S. In Biology
QC Associate Resume
Objective : QC Associate is responsible for managing the QA process for a product. This includes managing the team, and defining the QA strategy. Manage development teams to ensure quality of products by ensuring timely delivery and adherence to deadlines.
Skills : Microbiology, MS Office.
Description :
Obtained and tested samples of products and product bases to ensure they fall within desired specifications.
Read microbiological plates and release products for shipping.
Identified areas in production equipment that were receiving insufficient cleaning and brought the areas to the attention of sanitation.
Environmental Quality Control Experience following GMP, GDP, GLP, and laboratory safety practices Experience performing chemical and microbiological.
Left due to family illness.
Conducted quality control testing of molecular and cell biology products.
Used technical expertise, product knowledge, and communications skills to facilitate projects relating to the testing of products.
Experience
2-5 Years
Level
Junior
Education
B.S. in Biology
QC Associate Resume
Objective : QC Associate will also be responsible for taking responsibility for the overall development of quality assurance tools and procedures, as well as developing software systems to support their work.
Skills : Quality Analyst, Testing Skills.
Description :
Hands-on bench work with testing and troubleshooting of products using cGMP.
Ensured that sales reps adhered to specific requirements for the setup and installation of electronic displays.
Applying cGMP and other established protocol in all facets of work, aseptically Biological indicator (BI) testing Microbial (bacteria and mold).
Setting up Sample Vials, Weighing Vials & Film samples with products inserted.
Processing Quick Samples, Capacity Samples, and Opening Forces on vials.
Made sure parts were in spec. that performed microbiology testing on company products.
Tested products (vitamins) for bacterial contamination and performed bacterial identification.
Experience
2-5 Years
Level
Junior
Education
B.S. in Biology
QC Associate Resume
Objective : QC Associate ensures the product quality meets the company’s quality standards and is a key member of the product management team.
Skills : Serial dilution, Plate streaking, Enumeration Through Viable Plate Count.
Description :
Provided accurate and reliable analytical tests through laboratory analyses of FINISHED PRODUCTS.
Performed chemical testing like Assays, IR, UV.
Discard any reviewed and approved samples used for the analysis according to in-house methods to keep the laboratory area clean and safe.
Reviewed, before starting running samples, that all requirements are in accordance with the Product Method Procedure.
Processed run sample and report results in the system.
Performed Environmental Monitoring of Mfg. clean room; Surface viable, Air Viable and Nonviable testing for EM Sampled city water, WFI, RO/DI water systems ports.
Conducted bioburden testing.
Experience
2-5 Years
Level
Junior
Education
B.S. in Biology
QC Associate Resume
Objective : QC Associate is responsible for quality assurance, testing, and validation of products. This includes identifying the product’s requirements and requirements of the customer, developing and conducting test plans to ensure they are followed, and piloting new features to ensure they work as expected.
Skills : Plate streaking, Enumeration Through Viable Plate Count, Large Scale Column Chromatography, Sampling.
Description :
Performed Protein impurity and characterization analysis by Capillary Electrophoresis, icIEF, osmolality, and SoloVPE (A280) of In-Process.
Execution of method validation and transfer protocols.
Created and revised methods and operating procedures for routine use.
Performed Assay compliance.
Carried out immunoassay experiments for Quality Control purposes.
Implemented training courses for new technicians.
Performed 75% Environmental Monitoring of downstream production area.
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