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 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 Quality Specialist, with guidance from the Quality Manager or IPT Quality Lead, ensures product / process quality, performs activities to facilitate the release of product to the marketplace, and ensures proper control of material.
The Quality 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 by the functional area. Specific responsibilities include but are not limited to the following:
Qualifications: Education Minimum Requirement:
- Becomes fully trained in Merck Quality SOPs, production SOPs as needed, and SAP functions as required by Quality Specialists.
- Learns cGMPs, the manufacturing process, and Merck quality systems.
- Responsible for the review and release of filled container batches destined for both domestic and international markets.
- Prepares and submits release protocols to CBER. Prepares CoAs to support regulatory filings.
- Works cross-functionally to resolve outstanding issues from the manufacture or testing of the batch (e.g., batch record review, investigations, testing, CRs, etc.) to ensure the timely submission/release of the material.
- 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.
- Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support.
Required Experience and Skills:
- 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 significant relevant experience.
Preferred Experience and Skills:
- At least one year of relevant post-degree work experience in GMP-related field, including Technical, Engineering, Quality or Operations.
- 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.
- Effectiveness and creativity in approaching and solving technical problems
- Attention to detail, flexibility and an awareness of production and quality control problems.
- 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)
- Familiarity with vaccine and/or pharmaceutical processing.
- Familiarity with batch dispositioning (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.
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. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. 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.
Visa sponsorship is not available for this position.
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