BioPharma Consulting JAD Group

Quality Assurance Specialist - Drug Product NPI and Validation

BioPharma Consulting JAD Group  •  Juncos, PR (Onsite)  •  57 minutes ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

Provide Quality oversight for drug product operations at a leading biotechnology company in Juncos, Puerto Rico, with a focus on new product introductions, change control and validation. You will work with minimal supervision and make the quality calls that keep projects and product moving.

What you'll do

  • Represent QA on new product introduction (NPI) teams and support FATs.
  • Review and approve process validation protocols and reports, including PPQs.
  • Approve change controls, planned incidents, nonconformance investigations and CAPA records; act as QA designee on the change control review board.
  • Review and approve master production records, risk assessments, work orders and EMS/BMS alarms.
  • Lead investigations and site audits and own site quality program procedures.
  • Provide lot disposition and authorize lots for shipment.

Requirements

Benefits

BioPharma Consulting JAD Group

About BioPharma Consulting JAD Group

BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.

Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.

We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.

BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.

Industry
Biotech & Life Sciences
Company Size
11-50 employees
Headquarters
Cambridge, MASSACHUSETTS
Year Founded
2010
Social Media