Quality Assurance Project Manager

Portsmouth, NH

Posted: 05/17/2019 Job Number: JN -052019-10771
Quality Assurance Project Manager II

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Quality Assurance Project Manager II
Location: Portsmouth, NH
Industry: Biopharmaceutical, Biologicals
Hours: 1st Shift Monday-Friday, 8am-5pm
Salary: $80,000-$90,000k (depending on experience), plus relocation assistance for right candidate
Employment Type: Direct hire

The QA Project Manager II is assigned as the primary liaison to an external customer (or customers) for all quality-related items including temporary and permanent change controls, deviations, standalone investigations, CAPAs, Product Quality Reviews and Quality Agreements and facilitates discussions between customers and internal groups such as MSAT, Manufacturing, Engineering and QC. For these quality-related items, the incumbent manages the process for notifying the customer and assuring the customer s feedback and comments are addressed, verifies that the quality records are complete; that there is sound justification/scientific rationale, that root cause analysis and corrective and preventive action is appropriate and, where applicable, that customer approval is received. The QA Project Manager II leads Joint Quality Team meetings establishes agendas, publishes meeting minutes and tracks action items; participates in Internal and Joint Project Team (IPT/JPT) meetings as the QA representative and tracks and publishes monthly and quarterly quality KPIs.
  • One will Interact with internal and external customers as part of joint and internal project teams serving as the Quality Subject Matter Expert (SME) for any customer related quality issues. In addition, partners with internal customers such as MSAT, Manufacturing, and Engineering etc. as part of the change control process serving as the Quality SME and/or final QA approval.
  • Supports the Deviation, Investigation, and CAPA processes specific to their assigned customers; reviews and approves investigation reports including root cause analysis and assures corrective and preventive actions address the root cause to prevent recurrence.
  • Manages and tracks customer Key Performance Indicator quality metrics
  • Reviews and approves various product specific documents as needed such as Quality Agreements, Product Quality Reviews, etc.
  • Identifies opportunities for improvement, defines the project plan, scope, and deliverables Represents department at site meetings (lot release, CC and CAPA board) Supports Customer audits and Regulatory inspections
  • Bachelor s Degree or equivalent experience. Preferred area of study: Scientific related field
  • Strong experience in GMP environment. Extensive experience in Quality Assurance or similar discipline. Biotechnology, biopharmaceutical manufacturing background is preferred
  • Knowledge of GMP s and regulations; experience working within a CMO is highly preferred
  • Project Management Experience: Presentation, Customer Liaison, Meeting facilitation
  • Experience with Trackwise, SAP, Syncade and Microsoft Suite preferred
  • Demonstrates quality decision making
  • Self-starter, excellent written and verbal communicator at all levels, able to tolerate challenging workloads and changing priorities, attention to detail, works effectively individually and with teams, positive attitude, customer focused, works well under pressure
Search words:
PM, Project Manager, QA, Quality Assurance, Biological, Biopharmaceuticals, manufacturing, deviations, CAPAs, investigations, compliance
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