QC Analyst Job Description
QC analyst
provides technical expertise as a subject matter expert in the implementation, execution and troubleshooting of analytical methods within the cGMP testing laboratory.
QC Analyst Duties & Responsibilities
To write an effective QC analyst job description, begin by listing detailed duties, responsibilities and expectations. We have included QC analyst job description templates that you can modify and use.
Sample responsibilities for this position include:
Familiarity with stability testing, protocols, approval
Familiarity with analytical testing techniques using HPLC/GC/FTIR/Dissolution/UV and familiarity with LIMS/Empower/ Agilent GC software
Preparation of Annual product reviews
Interaction with operations, product release and logistics group to ensure timely release of analytical data
Testing of finished product, raw materials, packaging and stability
Perform analytical testing - HPLC, SDS, FTIR, UV
Interact directly with regulatory agency inspectors during audits
Team Leadership - active participation team development
Actively involved in investigations LIR’s
Perform accurate analytical testing equipment verifications in accordance to procedures or SOPs
QC Analyst Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QC Analyst
List any licenses or certifications required by the position: TS16949, AALAS, ASCP, GMP, CFCS, CFE, CPA, CAMS, PMI, LAPP
Education for QC Analyst
Typically a job would require a certain level of education.
Employers hiring for the QC analyst job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Chemistry, Science, Biochemistry, Biology, Microbiology, Education, Life Sciences, Associates, Technical, Molecular Biology
Skills for QC Analyst
Desired skills for QC analyst include:
Biological test procedures
Scientific theories
CGMP QC laboratory environment
Equipment associated with testing of biopharmaceutical products
Microsoft Word and Excel
Good laboratory practices
Quality control principles
Principles and techniques used in analytical
CGMP
CGMP and safety standards applicable to a pharmaceutical environment
Desired experience for QC analyst includes:
Requires strong knowledge of operational risk management processes for a significant, complex and/or large scale business
Experience working with Credit Card and Merchant Services processes and workflows preferred
A minimum of 2 years experience in a laboratory-testing environment within the
Science or related degree
Analytical instrumentation experience is essential
A BSc Degree in Science or equivalent
QC Analyst Examples
1
QC Analyst Job Description
Job Description Example
Our innovative and growing company is looking for a QC analyst. 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 analyst
- Problem solving of analytical methods troubleshooting of equipment
- Providing analytical support in various forms such as stability analysis, method development, out of specification investigations
- To be responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures
- Assist in data trending, data review, and lab maintenance activities
- Troubleshoot problems encountered with existing analytical methodology and instrumentation
- Experimental design and execution of lab experiments
- Conducts analysis associated with clinical and non-clinical laboratory studies under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) International regulations
- Perform basic wet chemistry analysis and analytical techniques on products and raw materials
- Report data and record results
- Conduct quality control analysis for in-process, finished good product, and stability of samples according to SOP (Standard Operation Procedures) and/or guidelines
Qualifications for QC analyst
- Able to perform shifts
- Understanding of medical device quality system requirements (21 CFR 820, ISO 13485, ) in appropriate application to quality control and manufacturing processes, change qualifications, verification and validation activities
- Strong expertise in data manipulation and analysis of large data sets using excel, and statistical analysis software such as JMP, minitab
- Three to eight years of industry experience with functional analysis QC or method development of molecular-biology-based assays preferred
- Molecular biology laboratory skills such as multichannel pipetting, PCR, required
- Experience with analytical assays and equipment such as UPLC, ICS, LCMS, liquid handling robots
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QC Analyst Job Description
Job Description Example
Our company is looking for a QC analyst. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QC analyst
- Performing tests and monitoring lab equipment
- Recording analytical data in a timely manner and initiating corrective actions
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations
- Performs automated and manual assays for raw materials, controls and reagents such as plasma screening final product QC testing and value assignments
- QC product testing & final testing to make sure they're hitting the proper marks, and would also need to be able to document and record data
- Analyze automated adjustment reports
- Oversee required training deadlines are met
- Responsible for sample receipt and management in the QC laboratory
- Responsible for the execution of sample testing at Intarcia including in process, intermediates and final DP samples to support the release of commercial final product
- Ensures testing is completed per schedule and within TAT
Qualifications for QC analyst
- Demonstrated knowledge of analytical equipment and instrumentation utilized for the testing of APIs, associated drug product, and raw materials
- Proficiency in basic computer software and hardware applications
- Experience handling biological and chemical materials (PCR reagents, buffers)
- Third level qualification in Microbiology or related discipline, preferably BSc in Microbiology
- A minimum of 2years’ experience working in a pharmaceutical or related industry in the field of Microbiology
- Biochemistry degree or relevant equivalent
3
QC Analyst Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of QC analyst. 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 analyst
- Supports the implementation of various computerized systems, as needed
- Performs a wide variety of analytical chemistry or biochemistry testing to support utilities, raw material, in process and bulk drug substance release
- Maintains laboratory reagents and supplies
- Provides support and advice to manufacturing on QC related topics
- Make safety the number one priority within the testing lab, everyday
- Comfortable working with chemicals in a lab environment
- Manage inventories of various lab chemicals, both with SAP and for non-inventoried consumable chemicals
- Test samples using instrumentation required in the procedure, pH meters, turbidity meters, titrators, spectrophotometer, centrifuge, electrodes
- Support manufacturing schedule 20-50% of the time
- Calculate adjustments to solutions that do not comply with tolerances
Qualifications for QC analyst
- Level 8 Chemistry Degree
- Biochemistry degree or relevant equivalent and three years analytical experience in areas such as ELISA, Biacore, and Electrophoresis techniques
- Has knowledge and understanding of biochemical techniques and analytical disciplines aligned to chemistry in the context of biopharmaceutical product release
- Computer literate and competent in the use of corporate IT systems and software analysis packages
- Biochemistry degree or relevant equivalent and three years analytical experience
- To understand the principles of immunological assays
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QC Analyst Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of QC analyst. 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 analyst
- Mentors and assist with peer training and review
- Perform Capillary Gel Electrophoresis, Charge Variant analysis and Western Blots as needed
- Collaborate - Actively listen and seek to understand differing perspectives
- Act with Candor and Courage - Speak openly, honestly and with conviction
- Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards
- Supervise the day-to-day operations of assay testing in QC
- Responsible for generating monthly and annual control logs for all assays performed in the Screening Laboratory
- Provide annual retraining to Laboratory staff
- Batch and process large amounts of data through a custom database system for marketing communications
- Inventory and equipment management of ongoing clinical and commercial stability programs
Qualifications for QC analyst
- GMP and FDA experience preferred
- Experience with analytical assays and equipment such as UPLC, ICS, LCMS a plus
- Experience writing automation protocols for liquid handling robots (such as Hamilton, Eppendorf, Tecan) strongly preferred
- Programming skills with object-oriented programming languages is highly regarded
- A Bachelor's degree (B.S.) or equivalent experience in Analytical Chemistry or related life sciences field with one to three years related experience and/or training
- Demonstrated knowledge of analytical equipment and instrumentation, HPLC experience working in a GMP environment is preferred
5
QC Analyst Job Description
Job Description Example
Our growing company is looking to fill the role of QC analyst. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for QC analyst
- Evaluates results of tests to verify that STB data in raw, repository and scheudlized states are as expected
- Documents STB testing issues and assists development team with concise and detailed steps for duplication of the problems found while performing tests
- Assist fellow team members and customers with problem reporting and resolution and maintaining appropriate follow-up communications throughout the resolution process
- Contributes towards QC estimation and scheduling process
- Conduct the physical and chemical analysis of in-process and finished products
- Inspect job request samples form lab batch, validation batch, stability study sample, CIP, NPD/NPI sample
- Prepare Analytical test report and related GxP document
- Maintain the calibration and preventive maintenance program of lab equipment as per schedule
- Support and contribute to Lab initiatives
- Record deviations from the normal practice and out of specification results appropriately and report
Qualifications for QC analyst
- Minimum of 2 years Biotech industry work experience
- Previous experience in QC role with significant experience in PCR
- Proficient with Excel and other data analysis tools
- A third level qualification (BSc degree or higher) in biology, chemistry or related field
- Experience with electronic systems such as LIMS, SoftMax, Statlia, Qumas, eDoc, Trackwise would be an advantage
- Adaptable and flexible individual, willing to travel when needed