About the position
The QC Analyst will be responsible for routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This position is based at Genezen’s new state-of-the-art facility in Lexington, MA. This role supports the daily and occasional weekend operations within the Quality Control group via execution of analytical testing and Quality Systems. This includes but is not limited to in-process testing, lot release testing, and stability testing. Execution of quality systems entails deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter-departmental policies and standard operating procedures.
Responsibilities
- Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, HPLC, Osmolality, Western Blot, etc.)
- Perform peer review with minimal errors.
- Work effectively in internal/cross-functional teams as an active member.
- Train and execute assays cross-functionally to support deadlines for release.
- Participate in equipment validation, method transfer/validation, and special protocol execution.
- Responsible for protocol and report generation/revision/review, as required.
- Strong understanding of regulations, able to apply to any situation, and identify deficiencies with some guidance.
Requirements
- BA or BS in Chemistry/Biochemistry or other related science.
- Minimum 0-5+ years of laboratory base experience within QC testing capacity, preferably in cGMP environment.
- High proficiency in q-PCR and HPLC methods and analysis.
- Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+.
- Understanding of industry testing requirements/standards.
- Computer literacy (MS Word, Excel, and LIMS).
- Good/effective communication and organizational skills with the ability to work well with others and independently.
Benefits
- Paid vacation days, amount based on tenure.
- Paid sick time.
- 10 observed holidays + 2 floating holiday + 1 volunteer day.
- 401(k) plan with company match up to 6% of salary, vested immediately.
- Share Appreciation Rights.
- Choice of several healthcare plans.
- FSA and HSA programs.
- Dental & vision care.
- Employer-paid basic term life/personal accident insurance.
- Voluntary disability, universal life/personal accident insurance.
- Accidental Death & Dismemberment (AD&D) Insurance.
