QA Associate I, Hollowfiber - Repligen Corporation : Job Details

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 Quality team in Marlborough, supporting Hollow Fiber and Single Use ATF Manufacturing.

The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System, reviewing production records and releasing product, as well as supporting other QA team members and areas of work, as needed.

The successful candidate will have a positive attitude and be able to communicate effectively. This candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing teams to ensure accuracy of production documentation throughout the production process. This position involves completing the QA review of production records, including but not limited to; verification of raw materials used, verification of calculations, good documentation practices, and processing steps have been completed according to the internal processes.

Responsibilities

• Review production records for compliance to ISO standards and internal processes.
• Process SAP transactions to accept and release batches.
• Review/approve the root cause, investigations and dispositions of non-conformances, deviations and other quality related events.
• Create/revise documents, spreadsheets and presentations using Microsoft Office.
• Participate in daily/weekly/monthly meetings.

Qualifications

Requirements:

• A BA/BS degree (in a Biological Science, Engineering, or Physical Science) is preferred but not mandatory.
• Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent.
• Ability to identify and ensure active and thorough investigations of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) is highly preferred.

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