Sr. Specialist, Quality Systems Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Quality Sr. Specialist ensures product/process quality via quality system adherence. The Quality Sr. Specialist evaluates existing and planned development activities to ensure alignment with key Quality Systems and ongoing Quality Assurance. He or she provides support to include oversight for adherence to cGMPs,
The Quality Sr, Specialist is knowledgeable in federal, and other regulatory agency requirements and cGMPs to ensure that all areas are in compliance, and will train on and gain competency in activities to ensure quality and compliance of product manufactured. The Quality Sr. Specialist performs job functions within a team environment. Specific responsibilities may include but are not limited to the following:
1. Evaluate the performance of key Quality Systems and Quality Assurance programs across sites as per the drivers of KPIs as identified by the Animal Health Line of Business (LOB) / MMD, including but not limited to:
- Market Actions
- Deviation Reduction
- Inspection Performance
- Customer Complaints
- Significant Investigations, including specifically those related to marketed product stability OOS results
- Health Authority notifications and communications
- CAPA and Commitment management (9-chart metrics)
2. Act as the primary liaison for the AH Quality Operations LOB Leader in assisting sites in complex compliance issues such as significant investigations.
3. Partner with the Site AH Quality Director and the Director, AH Quality Systems Compliance, to support sites, as needed, during regulatory inspection and Division audits. This includes driving cross-site proactive approaches (mock inspection prep work and Quality and Compliance Excellence activities). Assist in conduct of inspections, as needed, and assure regulatory responses are of high quality and represent both site perspective as well as Division perspective.
4. Co-ordinate a timely and effective internal escalation / external reporting processes for quality defects.
5. Support an effective Fact Finding process to ensure that investigations into quality defects that have the potential to result in market action or in Health Authority notification are completed in a timely manner, with coherent root cause investigation, associated effective CAPA identification, clear recommendation on HA notification / convening of the Recall Committee, and timely issuance of the Fact Finding summary memo.
6. Support AH Quality Operations LOB leader and Site Quality Heads to ensure high quality and timely Health Authority notifications and communications
7. Support AH Quality Operations LOB leader and Site Quality Heads on any recall activities by guiding sites in the preparation and follow-up of associated key activities
Partner with the Site AH Quality Director and Director AH Quality Systems Compliance, to ensure the overall compliance posture for the AH LOB is resilient and sustained.
Education Minimum Requirement:
- Bachelor's degree in a scientific or engineering field of study is required. Preferred fields of study include Biology, Biochemistry, and Microbiology. An MBA or other business degree, in addition to the required science or engineering education, is a plus.
Required Experience and Skills:
- At least eight (8) years of work experience in a pharmaceutical, biologics and/or vaccine manufacturing environment or a strongly related, similarly regulated field.
- Strong understanding of cGMPs, FDA, EU, USDA and EPA regulatory standards.
- Strong compliance mindset.
- Strong knowledge, experience, and/or certification in Six Sigma, and/or MPS/Kata
- Strong leadership skills and ability to work within a matrix organization to align on expectations and resolutions.
Preferred Experience and Skills:
- Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is preferred.
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. Our Company’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. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Sr. Spclst, Quality
Primary Location: NA-US-DE-Millsboro
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Delaware
Job Segment: Biochemistry, Microbiology, Engineer, CAPA, Law, Science, Engineering, Management, Legal