Qa Associate Ii

The Quality Assurance Associate II will report directly to the Manager or Quality Director.

This position is responsible to actively participate in the Repligen ISO 9001 Quality Management System. This role

is responsible for the Quality review and product release of manufacturing production records, including verification of raw materials used, verification of calculations and critical process steps.

Must have thorough understanding of Good Documentation Practices (GDP), identification and review and approval of Nonconformance and deviation investigations, able to perform root cause analysis and generate corrective actions to improve processes/systems.

• Assist with the maintenance of the Repligen Quality Management Systems (QMS), as assigned.
• Generation, review, and approval of quality investigations.
• Ability to participate in or lead quality meetings with multi-functional departments / individuals.
• Nonconformance and deviation investigations.
• Calculate KPIs and trend reports as required.
• Ability to identify, detect and escalate quality related trends.
• Support Customer, Suppliers, Internal, and ISO Audits.
• Support completion of Customer Documents / Questionnaires.
• Support incoming and in-process inspection of product and raw material
• Initiate and support Change Control, Deviations, Corrective Actions, etc.
• Technical Writing for Standard Operating Procedures (SOP) and Work Instructions (WI).
• Assist with the maintenance of the Repligen Quality Management Systems, as assigned.
• Lead QMS & Process Improvements to meet ISO 9001 compliance.
• Releases final product
• Perform other relevant duties as may be assigned by management.

Qualifications/Skills:  

·  Bachelor’s degree in Biological Science or other science related discipline.

·  Minimum 2-5 years’ experience in QA / QC, in an ISO 9001 certified Quality Management System or equivalent.

• Pharmaceutical or Medical Device industry experience a plus

·  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.

·  Lead/Internal auditor certification preferred.

·  Experience and knowledge of IT software platforms that support Quality Management Systems.

·  Understanding of Good Documentation Practices preferred.

• Familiarity with ASME, BPE, UL, and CE codes a plus.

Travel Requirements:

• Ability to travel to outside vendors to perform Supplier Audits based on business needs

Physical Requirements:

• Regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear.
• Frequently required to sit; reach with hands and arms and stoop, kneel, crouch, or crawl.
• Must regularly lift and /or move up to 25 pounds.
• Specific vision abilities required by this job include peripheral vision and depth perception.