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Quality Control Analyst
1 month ago
Analyst II, QC Bioassay
6 Months
Norwood, MA
- This analyst will primarily be focused on testing. Molecular biology & cell culture testing.
- Must-have 3 years of a GMP background
- Must have some of the following: qPCR, protein expression, sequencing, cell passaging, cell culture
Job Description
In this role, you will support cGMP QC testing for raw materials, drug substances, and finished products at the company's manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers, qualification activities, and ensuring compliance with cGMP standards. This is an on-site position.
Job Responsibilities
- Execute QC molecular biology and Bioassay methods (e.g. qPCR, sequencing, protein expression (cell based and cell free)
- Assist in troubleshooting equipment and assay issues.
- Perform general laboratory support activities including reagent preparation, equipment maintenance, housekeeping, logbook reviews, etc.
- Establish and maintain a safe laboratory working environment.
- Write, revise, and maintain SOPs, protocols, and reports.
- Support training as assigned.
- Assist in execution of Quality records (i.e. investigations, change controls, CAPAs)
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Additional duties may be assigned.
Education & Qualifications
Here’s What You’ll Need (Basic Qualifications)
- Education: BA/BS Degree
- Experience: STEM Degree with 3-5 years' of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell based assays
- Specific Certifications or Training: None
Here’s What You’ll Bring to the Table (Preferred Qualifications)
- Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods.
- Trained in Aseptic techniques and general laboratory instrumentation (e.g. pH meters, balances, pipettes)
- Ability to prepare reagents, pipette small volumes, work in a Biological Safety Cabinet
- Experience with laboratory equipment calibration and maintenance.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
