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 Product Team) operating model. The Quality Specialist, with guidance from the IPT Quality Leader or End to End Department Quality Leader, ensures product/process quality, represents quality on the shop floor, ensures adherence to Good Manufacturing and Documentation Practices, and completes quality checks and SAP transactions required to release product. The Quality Specialist performs 100% process document/log book audits for accuracy and completeness and works closely with the assigned IPT in a team environment to ensure timely review and documentation is done right first time. He or she provides Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, and effective investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor to partner with operations and technology to enable right first time production, to learn the manufacturing process, and to ensure compliance with cGMPs and regulatory requirements.
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 Focused Factory. Job functions are performed primarily on the production shop floor and in a team environment.
Primary activities include, but are not limited to:
- 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.
- Performs review of process documents/log books to ensure completeness and accuracy for assigned IPT. Maintains any tracking databases and logs associated with this review.
a. Reviews batch records, log books, and process environmental monitoring data (critical site review).
b. Coordinates with Production to discuss, resolve, and eliminate documentation defects.
4. Performs Quality review/approval of new and updated SOPs and Controlled Job Aids. Ensures compliance with departmental procedures.
5. Actively participates in the Tier process and uses this forum to escalate concerns and best practices.
6. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
7. Collaborates with IPT members to investigate deviations on production floor during shift.
8 . Works with necessary groups within the IPT to resolve outstanding issues with process documents/log books and GMP walkthrough inspection observations.
9. Reviews emergency stamps/hand stamps entered into batch records.
10. Ensure proper identification of release status and control to materials through maintenance of batch and stock status in SAP and through physical tagging of material as required.
11. Completes training to be a qualified auditor and completes monthly internal quality audits of the manufacturing areas in the IPT.
12. Performs Quality review of new and updated Master Batch Records (MBRs).
13. Provides coaching and mentoring of manufacturing managers and operators completing documentation.
14. Assists with training of incoming personnel.
15. Cross trains to support other functional quality areas including but not limited to deviation management, environmental monitoring investigations, and inspection support.
16. Completes training and is qualified to review qualification documents and change requests. Qualifications: • Education Minimum Requirement:
Bachelor's degree. • Required Experience and Skills:
- At least 1.5 years of experience in a quality, operational, or technical function supporting manufacturing.
- 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.
-Attention to detail, flexibility and an awareness of production quality control.
-Basic understanding of cGMPs and or regulatory requirements as they apply to the pharmaceutical field or a related area. • Preferred Experience and Skills:
- Familiarity with vaccine and/or pharmaceutical processing.
- Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus.
- Aseptic gowning may be required.
- Technical emphasis in a scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by relevant experience.
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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