Associate Analyst, QC Microbiology - LVV
About The Position
The Microbiology Lentivirus Vector (LVV) Manufacturing QC Associate Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and supporting process improvements. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5–15 other associates within the functional Quality Control laboratory and Manufacturing area. This role is part of the LVV team that positively impacts patients' lives by ensuring high quality in cell therapy products.
Requirements
- Minimum of a Bachelor's degree or equivalent required; a focused degree in Biological Science or an equivalent technical field preferred.
- Minimum of 0–1 years of relevant work experience.
- Experience in the biological and/or pharmaceutical industry.
- Microbiology experience related to manufacturing.
- Detailed knowledge of microbiology testing and sampling methods, techniques, and related equipment preferred.
- Experience with aseptic processing in an ISO 5 cleanroom and/or biosafety cabinets.
- Knowledge of cGMP regulations, Good Documentation Practices (GDP), and FDA/EU guidance related to the manufacturing of cell-based products is required.
- Excellent written and verbal communication skills.
- Highly organized and capable of working in a flexible team environment with a positive attitude under some supervision.
Nice To Haves
- Experience in a Quality Control setting.
- Experience working with cell therapy.
- Knowledge of FDA/EU guidance related to the manufacturing of cell-based products, as well as knowledge of Good Tissue Practices (GTP).
Responsibilities
- Lab support and equipment cleaning
- Participating in LVV manufacturing facility commissioning and qualification.
- Performing Routine Environmental Monitoring of classified areas within the Raritan LVV Facility.
- Performing compressed gas sampling in the LVV manufacturing facility.
- Performing environmental monitoring, APQ, and plate reads.
- Perform endotoxin testing of raw materials.
- Participating in gown qualification and re-qualification of personnel.
- Supporting Aseptic Process Simulations and visual inspection of components.
- Utilizing electronic systems (eLIMS) for execution and documentation of testing.
- Perform peer data verification/approval of laboratory data.
- Supporting process improvement teams.
- Performing tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (or 48/56 hours in CO/WA)
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
