Manager, Quality Assurance

JOB PURPOSE

Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for Batch Record Review, QA In-Process and QA In-coming Groups. Responsible for ensuring all the QA batch record documents approved for timely release of finished products and timely release of incoming materials.  Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging areas and ensure timely reporting of events.  Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. Responsible for directing and managing people and systems that assure product quality.

 

KEY ACCOUTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Directs the batch record review, incoming and in-process QA groups.
• Makes final accept/reject disposition on product lots and incoming materials.  Assures batch is manufactured in compliance with NDA/ANDA/EU, cGMP and Validation parameters. Ensures that records are reviewed and released in a timely manner.
• Coordinates communication for status of finished good lots, incoming materials and resolves issues related to accept/reject disposition of materials.
• Coordinates communication of production status to next shift; attends daily update meetings as required.
• Manages supervisory personnel for batch record review, in-process filling and inspection/packaging monitoring.
• Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR’s, Commissioning Documents, FAT’s), engineering documents.

• Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements.
• Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. 
• Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff.
• Places lots on HOLD if Quality issues are detected and notifies senior management.
• Assists the QA management in developing on department budget.
• Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions.
• Manages attendance records for all direct reports.

 

QUALIFICATIONS

• Minimum:    
• College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years’ experience, or Masters’ Degree in Microbiology, or biological science with 3-6 years’ experience
• Ph.D. in relevant field with 0-3 years’ experience
• Perferred:
• Additional college courses in Microbiology, cGMPs, Statistics or Quailty Management are beneficialnt 

 

EXPERIENCE 

• Minimum:   Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must
• Preferred:  Experience in Aseptic Manufacturing of injectable prducts is preferred

 

SKILLS

• Must have history of strong documentation skills and attention to detail
• Familiarity with cGMPs and CFR for US and EU
• Excellent organizational skills and ability to multi-task and perform work in a timely manner
• Demonstrates ability to lead a department, projects and meetings effectively
• Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management
• General computer skills and ability to prepare presentations and address large groups
• Demonstrated attention to details and accuracy

• The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must
• Menotring abilities as well as effective communication, (written and oral) are preferred.

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursem