
Senior Specialist, Lab Compliance
Welcome to Bristol-Myers Squibb, a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines to patients with serious diseases. We are currently seeking a highly qualified Senior Specialist to join our team and ensure compliance with all laboratory regulations and guidelines. This vital role requires a detail-oriented and experienced professional who is passionate about maintaining the highest standards of quality and safety in our lab operations. If you have a strong background in lab compliance and are committed to making a positive impact on patient lives, we encourage you to apply for this exciting opportunity.
- Ensure compliance with all relevant laboratory regulations and guidelines, including but not limited to FDA, GMP, GLP, and ICH guidelines.
- Develop and maintain policies, procedures, and standards for laboratory compliance.
- Conduct regular audits to identify any potential compliance issues and make recommendations for corrective actions.
- Stay up-to-date on changes in regulations and guidelines and communicate any updates or changes to the laboratory staff.
- Collaborate with cross-functional teams to develop and implement compliance training programs for laboratory employees.
- Monitor and evaluate laboratory processes and procedures to ensure they are in compliance with regulations and guidelines.
- Keep accurate and detailed records of all compliance activities and provide regular reports to management.
- Investigate and resolve any compliance-related incidents or deviations from established procedures.
- Work with external auditors and regulatory agencies during inspections and audits.
- Serve as a subject matter expert on compliance-related matters and provide guidance and support to the laboratory staff.
- Foster a culture of compliance within the laboratory and promote a strong understanding of the importance of following regulations and guidelines.
- Continuously identify areas for improvement in laboratory compliance and develop and implement solutions to address them.
- Collaborate with other departments to ensure overall company compliance with regulations and guidelines.
- Act as a liaison between the laboratory and regulatory agencies, providing necessary documentation and responding to inquiries as needed.
- Maintain confidentiality and integrity in handling sensitive compliance-related information.
Bachelor's Degree Or Higher In A Relevant Scientific Field Such As Chemistry, Biology, Or Pharmaceutical Sciences.
Minimum Of 5 Years Of Experience In A Laboratory Compliance Role Within The Pharmaceutical Industry.
In-Depth Knowledge Of Fda And Global Regulations And Requirements For Laboratory Operations And Compliance.
Strong Understanding Of Laboratory Quality Systems, Including Glp, Gmp, And Gcp.
Excellent Communication And Leadership Skills, With Experience In Leading And Managing Cross-Functional Teams.
Quality Assurance
Process Improvement
Data Analysis
Compliance Management
Risk assessment
DOCUMENT CONTROL
Training and Development
Auditing skills
SOP Development
Regulatory Knowledge
Gmp Expertise
Communication
Conflict Resolution
Customer Service
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Specialist, Lab Compliance in Princeton, NJ, USA is $80,000 to $110,000 per year. This can vary depending on factors such as experience, education, and the specific company or industry the individual is working in.
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Bristol-Myers Squibb Co. operates as a biopharmaceutical company, which engages in the discovery, development, licensing, manufacturing, marketing, distribution, and sale of biopharmaceutical products. It includes chemically-synthesized drugs or small molecules and products produced from biological processes called biologics.

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