| Description
Meet the new Merck. A stronger pipeline. More products to help people in more ways. More passionate than ever about what matters to our customers.
Merck and Schering-Plough are now one company. We recently merged to create a stronger, more diverse and more truly global company. This not only benefits our company and our shareholders, but it also benefits the millions of people around the world who rely on our products and expect us to continue to deliver exceptional value.
The Site Compliance Specialist supports GMP compliance activities by participating in audits, preparing for regulatory inspections, and reviewing procedures. Specific responsibilities include, but are not limited to:
- Conducting shop floor inspections, and participating in internal and divisional audits as well as pre-PAI assessments to ensure site readiness for regulatory inspections
- Evaluating manufacturing/packaging/laboratory facilities to assure compliance with internal, FDA and other regulatory agency requirements
- Facilitating and/or providing support for regulatory inspections by preparing daily minutes during the inspection, assisting the regulatory inspectors with obtaining required information, and coordinating the preparation of responses
- Providing experienced and mature judgment when performing special projects and investigations assigned by the Franchise Leader/Manager
- Coordinating the tracking of divisional audit commitments
- Performing and/or coordinating gap analyses for approved divisional guidance documents, regulatory guidance documents, and quality bulletins to ensure internal compliance
- Updating and/or reviewing Standard Operating Procedures and departmental written procedures for accuracy, consistency, and compliance with current GMPs and FDA commitments
- Actively conducting regulatory surveillance
- Training entry level personnel
- Understanding and conforming to all changes in federal and other regulatory agency regulations and assure that areas are in compliance.
Qualifications Education:
- A Bachelor of Science in a life science (such as Biology, Chemistry, etc.) or an appropriate Engineering field is required; candidates with majors in other fields will not be considered. A major in Biology, Microbiology, Biochemistry, Virology, or Engineering is preferred.
Required:
- At least two (2) years of experience, in broad based quality control and/or quality assurance audits or inspections, or other experience in a variety of manufacturing, packaging, testing, or technical support areas.
Desired:
- Experience in bulk vaccine manufacturing or other bulk vaccine support area is desirable.
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
To be considered for this position, please visit our career site at www.merck.com/careers to create a profile and submit your resume for requisition # QUA001929. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
|
