Sr Compliance Specialist

Fujifilm•College Station, TX

14h

About The Position

The Senior Compliance Specialist helps instill a ‘Quality Culture’ within the QC department by aligning compliance and continuous improvements to achieve Right-First-Time (RFT) results. The role supports CAPA implementation, and various training programs to enhance performance across QC sub-departments. Success is measured by on-time quality record closures, and reductions in CAPA aging. Additional functions and responsibilities of this role include but are not limited to participating in data integrity initiatives, internal/external audit findings, change controls, and periodic reviews. This position helps QC meet goals and milestones through sustainable and innovative process improvements while maintaining cGMP compliance.

Requirements

Work collaboratively with staff to maintain a ‘Quality Culture’ by coaching in the application of GMP Principles including the underlying rationale of those principles
Identify and escalate compliance risks, recurring issues, and schedule delays.
Practical understanding of cGMP regulations, GMP manufacturing and Quality Control.
Experience authoring CAPAs, change controls, and deviations.
Experience in deviation management systems such as TrackWise
Experience in quality document control systems such as Veeva
Technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative.
Excellent oral and written communication skills, interpersonal and organizational skills.
Excellent organizational and report writing skills
Proficient with Microsoft Office applications
Excellent 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 with and support team members in many different roles and functions.
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 and five (5) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Control or compliance role; OR Associate degree and seven (7) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Control or compliance role; OR High School Diploma or GED and nine (9) years’ experience in pharmaceutical or other regulated industry, preferably in Quality Control or compliance role.

Nice To Haves

Understanding of cGMP regulations associated to production of biologics.
Experience in Quality Control.

Responsibilities

Lead quality record closures to meet site metric goals/expectations.
Lead record review to identify and develop effective CAPA solutions and effectiveness checks.
Identify compliance risks, recurring issues, and schedule delays.
Support training programs in GMP principles, data integrity (ALCOA+), investigation techniques, RFT behaviors, and continuous improvements to enhance overall department performance and compliance.
Provide support in cross-functional Kaizen/A3 problem-solving sessions to streamline and optimize a range of QC workflows.
Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Lead the initiation of new deviations, and help lead this process along with CAPAs, and Change Controls.
Lead the timely implementation of document change controls (DCC).
Assist with the completion of periodic reviews to verify that SOPs, analytical methods, and associated forms are current, accurate, and aligned to the latest external standards and regulatory updates (e.g., USP, Ph. Eur., JP, ICH, WHO) and internal policies.
Draft, revise, and harmonize departmental SOPs, Work Instructions, Test Methods, Forms, Specifications, and Feasibility/Qualification/Validation Reports.
Assist with tracking audit observations and presenting audit findings for team awareness.
Participate and support internal and external audits, when applicable.
Provide awareness trainings of CAPA implementations across QC’s sub-teams.
Participate in site data integrity DI initiatives by addressing concerns including equipment and software, as applicable.