QC Associate Job Description
QC associate
provides internal distribution of cGMP materials for Manufacturing; following cGMP procedures; to provide accurate documentation and inventory reconciliation.
QC Associate Duties & Responsibilities
To write an effective QC associate job description, begin by listing detailed duties, responsibilities and expectations. We have included QC associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Perform routine Bioburden, Endotoxin, and environmental monitoring testing in accordance with SOPs, safety, and cGMP guidelines to support the release and stability of finished products, raw materials, in-process materials, and various components
Maintain up to date knowledge of cGMP, job related SOPs and complete all assigned training on time
Performs routine testing and data review of raw materials samples and, in-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment
Performs routine testing and data review of raw materials, in-process, release and stability samples of Bulk Drug Substance in a cGMP compliant environment
Performs receipt of raw materials, in-process, release and stability of the Bulk Drug Substance in a cGMP environment
Full understanding of basic cGMP expectations
Performs assays
Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, autoclaving, ordering and stocking supplies
Assist with coordination and management of day-to-day activities to ensure daily production targets remain on schedule, and appropriately escalate when targets are not met
Assist with training activities of fellow analysts
QC Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QC Associate
List any licenses or certifications required by the position: ACI, SOP, ISO, CSCP, CPIM, SQF, IFIC, CSC, CE, AWS
Education for QC Associate
Typically a job would require a certain level of education.
Employers hiring for the QC associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Chemistry, Biology, Microbiology, Biochemistry, Technical, Engineering, Education, Life Sciences, Life Science
Skills for QC Associate
Desired skills for QC associate include:
Analytical methods
Application of principles
Theories and practices of the chemist profession
GMP documentation
Related discipline
Incoming materials
CGMP
Procedures and practices in assigned area
USP
CGLP & cGMP
Desired experience for QC associate includes:
Working knowledge of BSA/AML and sanctions laws and regulations background in controls and best practices
Minimum three (3) years of relevant experience in a laboratory setting
Associates Degree/Certificate/Diploma in laboratory science with minimum of 2 years’ experience in related laboratory work
Detail oriented with ability to work effectively under high pressure with multiple deadlines
Ability to effectively carry out and implement change
Ability to put aside personal opinions and focus on business needs, department needs or group needs
QC Associate Examples
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QC Associate Job Description
Job Description Example
Our growing company is hiring for a QC associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for QC associate
- Ensures all safety procedures are followed by shift team members
- Ensures all quality procedures are followed by shift team members
- Guide the operational improvement and optimization
- Perform clean utility sampling Monitor critical operating parameters for equipment and instrumentation to ensure standard operation
- Recognize, report, and document deviations from test methodologies, specifications, and alert limits
- Coordinate sample receipt, logging, tracking, storage, distribution and archival
- Performs routine assays such as UV-VIS Spectrometry, SDS Page, Wet chemical analysis, various HPLC methodologies
- Aids in troubleshooting equipment and methods and performs some basic troubleshooting techniques
- Conducting visual and measurement tests
- Approves in-process production by confirming specifications
Qualifications for QC associate
- Extensive Karl Fisher Moisture and UV spectrophotometry experience
- Basic molecular biology laboratory skills such as pipetting, PCR, gel electrophoresis, required
- Bachelor's Degree in Biology, Microbiology or Chemistry
- SoftMax Pro and Nautilus LIMS experience a plus
- Computer proficiency including spreadsheets and databases is necessary
- BS/BA in biological sciences, or its equivalent in experience
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QC Associate Job Description
Job Description Example
Our innovative and growing company is looking for a QC associate. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QC associate
- Performs routine assays such as Bioassay, Biacore, qPCR
- Performs routine assays such as UV-VIS Spectrometry, Wet chemical analysis, utilities testing, and various HPLC methodologies
- Performs basic troubleshooting techniques of instruments
- Performs sample management including sample tracking, aliquot preparation and sample distribution
- Support the MT and MS& T groups for sample receipt and processing
- Communicates issues with sample processing to area lead or Manager
- Provide direct support to lab personnel to trouble shoot sample management issues
- Reconciles critical reagent inventory
- Prepares sample receipt and shipping activities across sites and to contract laboratories
- Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of the manufacturing facility
Qualifications for QC associate
- Build, develop and maintain LIMS templates
- Troubleshoot templates/specifications
- Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products
- 2+ years experience in a regulated microbiology laboratory preferred
- Familiarity with the use of air sampling equipment, autoclaves, micro ID methods, and endotoxin testing
- Experience requiring one to work independently part of a team, to complete assignments within defined time constraints
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QC Associate Job Description
Job Description Example
Our company is looking for a QC associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QC associate
- Performs wet chemistry compendial assays
- Assist in the development of processes and products
- Initiate NCR
- Lead OOS investigation
- Overseeing day to day operation of QC Stability (Stability protocol design and execution, stability chamber maintenance, interactions with partners and other collaborators
- Provide both technical and operational chemistry expertise (Biochemistry/Stability) for training, product investigations, deviations, CAPA, quality and operational improvements, to ensure continued compliance with regulations
- Providing leadership and direction to Quality Control supervisors and Managers and support teams to ensure product quality guidelines are consistently met
- Lead the stability topics in inspections conducted by external regulators and business partners to defend product shelf life
- Coordinate timely and right the first time delivery of stability results required by CMC Regulatory groups, and for support of Manufacturing groups and laboratory investigations
- Organize scientific study review, interpret data and draw reasonable conclusions
Qualifications for QC associate
- Demonstrated ability to concurrently conduct multiple routine tasks, procedures, and operations effectively and consistently
- BS Degree, or equivalent experience plus a minimum of 5 year’s industry experience in a QC role
- The ideal applicant would have GCP training, particularly in areas such as data reporting and clinical trial management, experience in written communication
- A minimum of 5 years of QC experience for a pharmaceutical company is preferred
- This position requires computer skills, such as Word, Excel and Power Point
- 0-2 years of QA/QC experience
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QC Associate Job Description
Job Description Example
Our growing company is looking for a QC associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for QC associate
- Advise Manufacturing, QA, RA, Facilities and Material Management of quality control stability requirements and stability issues associated with products or raw materials/Device
- Develop and validate new and existing Immunoassays (Including Nepholometry, ELISA, Electrophoresis Coagulation and flowcytometry assays)
- Writing protocols, reports and working with other Immunochemists to design and implement feasibility and validation programs
- Demonstrate leadership in the supervision and support of QC analysts with respect to timely implementation of projects
- Training, writing of documents and updating LIMS
- Manage change control, work with QA and RA to facilitate the updated processes
- Release and stability testing, as needed
- Authoring change control requests and quality technical reports, as needed
- Technical leadership through effective project management and input for decisions related to complex problem solving, while helping to manage non-complex problems routinely
- Leadership and mentoring as needed to aid in the development of their peers
Qualifications for QC associate
- A working knowledge of regulatory standards as they apply to biopharmaceutical manufacturing
- Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility
- Must be able to work on 2nd shift Wed-Saturday
- Clean weigh booth, equipment and any associated sampling areas
- Inspect incoming components and materials
- Identify non-conforming materials
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QC Associate Job Description
Job Description Example
Our innovative and growing company is hiring for a QC associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for QC associate
- Ensure optimisation of laboratory resources and operations in accordance with cGMP, regulatory and business requirements
- Manage the transfer of new project technologies and analytical methods
- Continuously improve analytical methodologies and laboratory systems to ensure continuing cGMP compliance and improve departmental cost efficiencies
- Effective participation in leadership or membership roles for site cross-functional teams as a representative of the QC Bioassay laboratory related to laboratory improvements and projects
- Perform routine Bioburden, Endotoxin, and environmental monitoring testing in accordance with SOPs, safety, and
- Assess compliance with BSA/sanctions related regulations and established Bank policies and procedures identify any potential and emerging BSA/sanctions/fraud risks or issues
- Directs the daily operation of a biologics QC department testing and reporting of raw material, utility, in process, and final bulk product samples to support the manufacturing of bulk drug substance
- Establishes and communicates performance objectives for QC staff that are consistent with the businesses unit goals, Quality and BDO objectives
- Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent
- Directs the efficient and timely technology transfer of methods
Qualifications for QC associate
- Plan, schedule and execute periodic retain and reserve inspections in compliance with written procedures
- Prepare and Store retain samples for raw materials and finished product samples
- Author and review Standard Operating Procedures, technical reports, specifications, change controls as required
- Assist in investigating any non-conformances or problems noted during the sampling/inspection process
- Basic fundamental understanding of mathematics
- Requires basic communication skills