Overview
The QA Inspector II will report directly to the Quality Lead or Manager.
This position is responsible for the day-to-day activities involved with the Repligen ISO 9001 Quality Management System.
Responsibilities
- Perform mechanical/functional/physical and first article inspection of incoming product from suppliers, including paperwork verification in conformance to established requirements or assist in other quality functions as needed.
- Perform in-process and final inspection of finished product which will include verification of components to engineering records and documentation requirements.
- Access and interpret engineering drawings, specifications, purchase orders, work orders etc. to determine quality status and support manufacturing.
- Prepares appropriate documentation and labels for quality and manufacturing/assembly process.
- Reviews manufacturing batch records against applicable quality requirements and document results of inspections.
- Identify and clearly communicate nonconformance’s to specified requirements to Management in timely manner.
- Organize QA inspection area. Support completed batch records scanning and records retention.
- Use Microsoft Office & other related software to accurately document and maintain associated paperwork and inspection results in a consistent and timely fashion.
- Provide QA floor support activities including participating in cost out activities, additional data collecting and maintaining Quality data storage.
- Identify and communicate continuous improvement opportunities for the quality program for internal and external customers.
- Perform other relevant duties as may be assigned by management.
Qualifications
Education and/or Work Experience Requirements:
- High School diploma or Two-year technical degree (ASME) or equivalent from an accredited technical institution is preferred.
- Machine shop experience in the quality discipline or a related field will be considered.
- Strong mechanical background, minimum 5-years’ experience.
- Familiar with medical devices, pharmaceutical, military or aerospace industry.
- Experience with ISO 9001, ISO 13485, 21CFR820 or equivalent QMS standards.
- Requires demonstrated use of mechanical inspection hand tools.
- Requires demonstrated use of basic Microsoft Office tools (Outlook, Excel, Word).
- Blueprint reading skills.
- Working knowledge of GD&T and familiarity with ASME BPE codes a plus.
- Knowledge of AQL Inspection plans.
- Team oriented with good organization skills.
- Good written and verbal communication skills.
- Must be able to remain in a stationary position
- Regularly required to sit, stand, use hands
- Occasionally move about inside office
Physical Requirements:
- Ability to work in a laboratory environment and exposure to hazardous materials
- Regularly required to stand, sit, walk, use hands and arms
- Lift/ or move up to 25 pounds
What Repligen Offers
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is USD $21.42/Hr. - USD $26.14/Hr.. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.