Facilities Compliance Coordinator II

The Facilities Compliance Coordinator II will be responsible for performing various aspects of tracking, coordination, and closure of CAPAs, change controls and deviations, and assists in supporting the timely release and disposition of batches and other post-execution activities.

Essential Functions

Work collaboratively with site management to instill a ‘Quality Culture’ by coaching Facilities staff in the application of GMP Principles including the underlying rational of those principles.

Support the Quality and Facilities 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 Facilities audit preparations, internal preparation for audits, assisting client audits with site documentation collation.

Coordinates the initiation of new deviations.

Leads deviation investigation, CAPA, and required cGMP documentation for Facilities, including initiation of New Product Introduction change controls.

Leads Root Cause Analysis Investigations.

Leads Problem Analysis (PA) events.

Leads After Action Reviews (AAR).

Schedules and facilitates lessons learned.

Leads the completion of periodic reviews.

Provides and maintains metrics around batch closure, including deviation, CAPA and change control status.

Responsible to manage document require to include in deviations, CAPA and Change controls.

Perform Facilities Trend Analysis.

Required Skills & Abilities

Excellent oral and written communication skills, interpersonal and organizational skills.

Excellent organizational, analytical, data review and report writing skills.

Practical understanding of equipment used in bioprocessing (downstream and/or upstream).

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.

Experience working in cleanroom environments.

Experience working with investigation of critical utilities (WFI, CDA, etc) and Facilities

Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the manufacturing facilities.

Requirements

Qualifications:

Bachelor’s Degree and four (4) years’ experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products; OR

Associate degree and six (6) years’ experience in Quality Assurance or GMP Compliance role supporting pharmaceutical, biopharmaceutical or biotechnology products

Preferred Qualifications

Experience with critical utilities, pest control, facilities, cell culture and purification processes

Experience authoring CAPAs, change controls, and deviations