Sr Compliance Specialist
On-siteCollege Station, Texas, United States
Job Summary
Lead quality record closures to meet site metric goals and develop effective CAPA solutions by identifying compliance risks and recurring issues. Promptly notify management of potential quality or regulatory issues affecting product quality and initiate new deviations, CAPAs, and change controls. Support training programs in GMP principles, data integrity, and investigation techniques while drafting, revising, and harmonizing departmental SOPs and work instructions. Participate in internal and external audits, present audit findings, and assist with periodic reviews to verify current SOPs and analytical methods. Provide awareness trainings across QC sub-teams and support cross-functional Kaizen/A3 problem-solving sessions to optimize workflows. Must work flexible hours including weekends as necessary.
Required Qualifications
- Bachelor's Degree and five (5) years' experience in pharmaceutical or other regulated industry, preferably in Quality Control or compliance role
- Associate degree and seven (7) years' experience in pharmaceutical or other regulated industry, preferably in Quality Control or compliance role
- High School Diploma or GED and nine (9) years' experience in pharmaceutical or other regulated industry, preferably in Quality Control or compliance role
- 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
- Must be able to stand for prolonged periods
- Must be able to bend, stoop, push, pull, reach above shoulders and stretch
- Must have hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
- Must be able to lift up to 25 pounds frequently and up to 50 pounds, on occasion
- Attendance is mandatory
Desired Qualifications
- Understanding of cGMP regulations associated to production of biologics
- Experience in Quality Control
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