Associate Specialist, Quality
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Quality specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model. Execution of the activities and responsibilities related to this position are designed to further develop the knowledge and skill foundation required to advance to other Quality-based functions within the organization.
The Associate Quality Specialist, with guidance from the Quality Manager or IPT Quality Lead, ensures product / process quality and compliance and performs activities to facilitate the release of product to the marketplace. The Associate Quality Specialist should be knowledgeable in current Good Manufacturing Processes (cGMPs) and relevant regulatory agency requirements, and will train on and gain competency in these areas to ensure quality and compliance of product manufactured by the functional area. Specific responsibilities include, but are not limited to, the following:
- Becomes fully trained in relevant Standard Operating Procedures (SOPs).
- Learns cGMPs, the manufacturing process, and Merck quality systems, including SAP, LIMS and electronic logbook and batch record platforms.
- Responsible for performing the Quality review of batch documentation.
- Participates in the Quality shop floor oversight program, including routine shop floor audits and review of documentation within the IPT to ensure compliance with cGMPs and regulatory requirements.
- Assists Quality Specialists in the review of batch release protocols documentation for both FDA (CBER) and for international markets.
- Works cross-functionally to review and update master batch documents to incorporate changes and/or updates to the records.
- Ensures compliance with departmental procedures.
- Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
- Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
- Ensure proper identification of release status and control of materials through maintenance of batch and stock status in SAP and through physical tagging of material as required.
- Assists with training of incoming personnel.
- Performs Quality review / approval of new and updated SOPs and job aids.
- Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by relevant experience.
- A minimum 1-3 years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
- Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Basic understanding of the use and maintenance for Microsoft applications (such as MS Excel, Outlook, and/or MS Access)
- Evidence of leadership skills coupled with good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Demonstrated teamwork skills and ability to work independently.
- Effectiveness and creativity in approaching and solving technical problems.
- Attention to detail, flexibility and an awareness of production and quality control problems.
- 3+ years of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
- Familiarity with vaccine and/or pharmaceutical processing.
- Familiarity with batch documentation review and/or shop floor auditing programs are a strongly preferred skill necessary for success in this position; prior experience in those areas is a plus.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Quality Operations
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck