QC Scientist I, MicrobiologyPurpose & Scope QC Scientist, Microbiology will provide support to the AIRM MA-TC GMP Environmental Monitoring (EM) program, and microbial testing. QC Scientist will be responsible for supporting review of EM and lab test results, technical writing/projects, and training/coaching team members. This role is scheduled for Monday to Friday First shift (8 am to 5 pm) supporting GMP operations.
Role and Responsibilities - Support day-to-day operations in QC Microbiology laboratories and the GMP facility.
- Reviews EM, lab test results, and documents for product testing, EM, and trend reports.
- Oversee the trending and reporting of environmental data.
- Be an SME/Trainer for microbial testing of media release, products testing for gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
- Be an SME for EM/lab assays and help with assay qualification, instrument troubleshooting, and procedure/report writing.
- Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
- Author any non-conformance, deviations, and OOS investigations-work with the team to find a root cause and corrective actions for out of specification results.
- Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
- Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at contract labs and CMOs.
- Support QC equipment validation, maintenance, calibration, and QC laboratories scheduling and maintenance.
- Participate and own technical projects/documents for process improvement and implementation, experience with rapid assays (CCIT, Mycoplasma, and Sterility) is required.
- Represent QC in cross functional meetings and provide support/feedback for microbial quality/contamination control of the facility.
- Collaboratively develop and maintain the facilities contamination control strategy.
Required Qualifications - B.S. degree in Biology/Microbiology with 8 years or MS with 4 years of relevant industry experience in a QC lab.
- Demonstrated experience of aseptic techniques and common microbiological testing.
- Supports/Mentors routine work, help/coach the team for testing or technical documents/projects
- Good documentation, data organization, detail oriented, and for quality and timely batch release.
- Must be capable of observing and adhering to lab safety standards and procedures
- Excels in a fast-paced team environment and completes assigned work in timely fashion.
- Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment
- This role is scheduled to work during day shift (8 am to 5 pm) on Monday to Friday and flexibility may be required to support GMP Operations.
Preferred Qualifications - Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
- Model our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and Compliance.
Location and Working EnvironmentThis position is based in Westborough, MA.
- Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
- Model our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and Compliance.
Salary Range$94,570-135,100 (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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