ABOUT COMPANY:
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.
Sterility Assurance Consultant Pharmaceutical (GMP, Data Integrity, CAPA, FDA Remediation)
JOB SUMMARY:
Our client, a pharmaceutical sterile manufacturing operation in Greenville, North Carolina, is seeking a Senior Consultant to support sterility assurance and GMP quality activities. This role covers contamination control, aseptic process oversight, deviation and CAPA management, data integrity, and support of FDA remediation commitments. This is a hands-on consulting role working closely with Manufacturing, Quality and Regulatory teams in a regulated sterile environment.
RESPONSIBILITIES:
- Provide sterility assurance oversight for aseptic manufacturing operations
- Support contamination control strategy, environmental monitoring programs and trend review
- Lead and support deviation investigations, OOS and OOT investigations and root cause analysis
- Author, review and drive CAPAs through to closure, including effectiveness checks
- Support FDA remediation commitments and ensure timely, defensible closure of observations
- Apply data integrity principles (ALCOA+) across records, systems and documentation practices
- Review batch records and support product disposition activities
- Support audit and regulatory inspection readiness, including preparation of evidence packages
- Review and approve SOPs, protocols and quality records for compliance
- Partner with Manufacturing, Quality, Validation and Regulatory teams on compliance initiatives
QUALIFICATIONS:
- Bachelor's degree in Microbiology, Biology, Chemistry, Engineering or a related scientific discipline
- 3 5+ years of experience in pharmaceutical quality, sterility assurance or GMP compliance
- Experience in sterile or aseptic pharmaceutical manufacturing
- Strong working knowledge of cGMP, 21 CFR Parts 210 and 211, and data integrity (ALCOA+)
- Demonstrated experience with deviation investigations, CAPA and root cause analysis
- Experience supporting FDA inspections, observations or remediation activities
- Preferred: environmental monitoring, media fills and aseptic process simulation, contamination control strategy, sterilization validation, 21 CFR Part 11
- Strong technical writing and documentation skills
- Ability to work onsite in Greenville, North Carolina
- Minimum 3 years of professional post-graduation experience required. This position is not suitable for recent graduates or current students
- Must be authorized to work in the United States without sponsorship, now or in the future
- W2 employment only
HOW TO APPLY:
Please send your resume to
deepika.b@starkpharma.com
along with your hourly rate expectation and your current location.