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Quality Assurance Compliance-1st Shift

Portsmouth, New Hampshire | Direct Hire

Job ID: 46713 Industry: Manufacturing

This leading pharmaceutical company in New Hampshire is now looking for a Quality Operations Compliance Specialist!

The specialist will serve as the liaison between internal Quality department and customer Quality. The specialist will ensure superior customer service to internal and external customers. Level and supervision received is commensurate with experience. The level 4 specialists will require little direction for day to day activities and coaching, direction and/or escalation of issues. The level 4 specialists will contribute and help define the strategy for remediation for escalations/issues and improvements efforts. Mentors less experienced staff on the team. 

Key Accountabilities  and Duties:

Interact with internal and external customer as part of Joint and Internal project Teams serving as the Quality Subject Matter Expert.

Reviewing and approving various product specific documents, as needed, such as Process Validation Reports, Quality Agreements, Annual Product Reviews, Deviation Reports and Change Controls.

Support Customer and/or Regulatory audits and inspections

Mentorship of External Quality Operations Specialists levels 1-3

Manage and track Key Performance Indicator Quality metrics

Perform other duties as assigned

Minimum Required Qualifications/Skills:

Preferred area of study:  Scientific related field

Advanced Career Experience in a GMP environment and in Quality Assurance or similar discipline. Biotechnology manufacturing background is preferred.

Knowledge of GMP’ s and regulations

Experience with Trackwise, SAP, Syncade and Microsoft Suite preferred




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, confident making quality decisions, able to motivate others.

Don' t feel you are the best fit for this job but know someone who is?  Refer someone who is hired for this role (or ANY other) and we will offer you a referral bonus for helping us to keep our client happy.

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QA, Bio, Pharm

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