Sr. Manufacturing Compliance Specialist
Summary: The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation investigations through to completion. Support all internal and external audits. Work collaboratively with cross functional groups including Quality Assurance to support ‘on-time' release and disposition of batches and other post-execution activities.
Responsible for the following activities within the Manufacturing Support Services function:
- Own all deviation, CAPA, and change control closure for Manufacturing, including initiation of New Product Introduction change controls.
- Own all Root Cause Analysis Investigations.
- Own all Problem Analysis (PA) events.
- Owns all After Action Reviews (AAR).
- Drives continuous improvement of batch related documentation.
- Work collaboratively with site management to instill a ‘Quality Culture' by coaching Manufacturing staff in the application of cGMP Principles including the underlying rational of those principles.
- Support the Quality and Manufacturing organization during internal and supplier audits.
- Support the external and internal Audit Programs to be in an acceptable state of compliance
- Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
- Responsible for Manufacturing audit preparations, conducting internal, external and regulatory audits.
- Coordinate batch and formulation record review and corrections to executed records.
- Coordinate the initiation of new deviations.
- Schedule and facilitate post manufacturing campaign lessons learned.
- Leads the completion of periodic reviews.
- Provides and maintains metrics around batch closure, including deviation, CAPA and change control status.
- Support Compliance Coordinators to aid 100% on-time closure of all quality related investigations.
Required Skills & Abilities:
- Must have a working knowledge of cGMP regulations associated to production of biologic drug products.
- Excellent oral and written communication skills, interpersonal and organizational skills.
- Excellent organizational, analytical, data review and report writing skills.
- Thorough understanding of all aspects related to cGMP manufacturing.
- Thorough understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream).
- Thorough understanding of closure requirements associated to working in a ‘Ballroom' manufacturing facility.
- Proficient user of deviation management systems such as TrackWise.
- Proficient user of quality document control systems such as MasterControl.
- Proficient with Microsoft Office applications.
- Good self-discipline and attention to detail.
- Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
- Ability to multitask and easily prioritize work.
- Ability to work independently with little supervision.
- Must have good planning skills and must be willing to interface colleagues across all levels of the FDB network.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
- Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
- Attendance is mandatory.
- Bachelor's degree in related science concentration with 6 years' experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products; OR
- Master's degree in related science concentration with 4 years' experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products.
- Experience with cell culture and purification processes.
- Experience working in a cGMP environment with exposure to good documentation practices.
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.