Overview
Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs.
We are currently seeking a QA Associate I to join our TangenX Quality team in Marlborough.
This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role is responsible for the Quality review of TanGenX Cassette manufacturing production records, including verification of raw materials used, verification of calculations and critical process steps, and evaluation of Quality Control testing.
Responsibilities
Responsibilities:
- Perform batch record review; to include review of production records, quality control records such as (i.e.:, monthly RO/DI, weekly Environmental Monitoring records), and weekly/monthly logs
- Identification of process deviations
- Identification of Out-of-Specifications (OOS) results
- Label Verification
- Assist with the maintenance of the Repligen Quality Management Systems, as assigned
- Bind and file completed batch records and other administrative activities
Qualifications
Bachelor’s degree in Biological Science or other science related discipline
- Minimum 0-2 years’ experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent
Must be familiar with Quality Control principles and concepts such as (i.e.: Bioburden/ Endotoxin Testing, RODI testing, pH, Conductivity etc.).
Must be familiar with Good Documentation Practices (GDP) and able to perform root cause analysis, assist with deviations and identification of corrective actions/ Process improvements.
- Ability to communicate with multiple departments and associates
- Shares timely information with peers on daily progress
- Ability to contribute to project teams
- Focus and attention to detail is critical
What Repligen Offers
Excellent Benefits!
- Health Insurance available on day one
- 4 Competitive Medical Plan Options
- Dental, Vision, Life and Disability Insurance Plans
- 401K
- Health Care Savings Account
- Well Being Programs
- 20 Days of PTO
- Tuition Reimbursement Program