Scientist Biopharma Manufacturing Quality Control Analyst II Microbiology SFD-TC, Quality Control - NCPurpose & Scope This resource will be part of the Quality Control Microbiology team located at the Sanford TC in Sanford, NC, and will be responsible for environmental and utility sampling and testing, as well as additional lab functions as needed. This role will support QC testing for any products manufactured at the Sanford TC.
The Analyst II, Quality Control Microbiology will be responsible for implementing and executing microbiological testing in support of clinical and commercial products in compliance with GMP requirements. This role will also support testing for stability studies, method validation studies and equipment validation.
Role and Responsibilities - Schedule Environmental and Utility Monitoring, ensuring all samples are collected as required
- Perform Environmental and Utility Monitoring
- Author/revise technical reports and laboratory procedures
- Author/review electronic database improvements
- Assist in data trending and summarization
- Participate in deviation and OOS investigations
- Perform plate reading and generate microbial isolates
- Receive, unpack and organize supplies for QC areas
- Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP
Other duties as required:
- Perform release, stability, and in-process testing supporting production activities. Testing includes, but is not limited to bioburden, endotoxin, pH/conductivity
- Perform growth promotion/media qualification
- Perform testing in support of method transfer/validations
- Participate in equipment qualification/validation studies
- Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
Required Qualifications - B.S. Degree in Microbiology, or other science-related degree, with 0-2+ years' relevant industry experience in a quality control role.
- Demonstrated experience of aseptic technique and common microbiological and environmental monitoring testing.
- Knowledge of relevant compliance and guidance documents.
- Must be able to gown into cleanrooms in support of testing and manufacturing activities.
- Good documentation and data organization.
- Detail oriented and willingness to learn.
- Strong interpersonal skills which contribute to a supportive and positive work environment
- Proven history of working in a fast-paced team environment, time management, and meeting deadlines.
- Highly collaborative team player with the ability and willingness to support other colleagues in the Quality Control department.
- Flexibility to cover off-shift work (e.g., weekends) will be required.
Preferred Qualifications - Experience in a small company and high growth, fast-paced environment
- Experience in qualification of analytical equipment, including those with computerized systems
- Experience in method validation/qualification/verification/transfer
Location and Working Environment- This position is based in Sanford, NC and will require on-site work in a cGMP regulated manufacturing facility.
- This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
Salary Range$69,790-$99,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
Benefits:- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions
- Referral bonus program
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