For Quality services in the PR01 Plant
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's degree in Engineering or Life Sciences with five (5) + years of experience in leading Deviation Investigations within the pharmaceutical, biotech, medical device, or other regulated manufacturing environment.
- Experience in:
- Conducting and documenting investigations related to deviations, nonconformances, and quality events.
- Electronic quality systems (Trackwise, Veeva, etc.)
- Root cause analysis tools and structured problem solving.
The Personality Part:
- If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead, then this is the job for you! Sprinkle on a love for the scientific method, teamwork, and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Lead end to end investigations for deviations and quality events.
- Gather and analyze data, interview personnel, and review documentation to understand event details.
- Apply structured root cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone, Fault Tree,).
- Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
- Identify true root causes supported by evidence.
- Develop effective CAPA plans that address root causes and prevent recurrence.
- Partner with process owners to ensure CAPA implementation, effectiveness checks, and closure.
- Prepare clear, concise, and compliant investigation reports.
- Ensure documentation meets GMP, and regulatory expectations.
- Maintain high standards of accuracy, clarity, and traceability.
- Work closely with Operations, Quality Assurance, Engineering, Maintenance, and other departments.
- Facilitate investigation meetings and lead cross-functional problem-solving sessions.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?
Top Skills
What We Do
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
