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, 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/logbook review/audits for accuracy and completeness and works closely with IPT in a team environment to ensure timely review and documentation is Right First Time (RFT). He or she provides support directly to the production floor, to include oversight for adherence to cGMPs, RFT completion of production GMP documentation, and effective investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor, collaborating with Operations and Technology to enable RFT 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 IPT. The Quality Specialist performs job functions both independently and within a team environment. Specific responsibilities include but are not limited to the following:
- Performs Quality batch record review and approval.
- Performs batch record issuance to the shop floor.
- Performs Quality review and approval of master batch record updates.
- Performs domestic and international batch release.
- Creates batch release protocols for international markets.
- Collaborates with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates.
- Performs Quality review and approval of new and updated SOPs and Controlled Job Aids.
- Performs GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements.
- Assists with training of incoming personnel and 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.
- Maintains metrics associated with batch release, batch record review and GMP walk through inspection.
- Bachelor's degree
- Degree concentration in a scientific or engineering field
- At least two years of relevant post-degree work experience in a quality, operational or technical function supporting manufacturing.
- Evidence of leadership skills coupled with good oral and written communication skills.
- Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
- Familiarity with GMP documentation review is a key skill necessary for success in this position.
- Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is preferred.
- Familiarity with finished goods packaging process.
- Experience in batch release.
- Experience in SAP is a key skill necessary for success in this position.
- Experience with data collection and associated graphs/ charts generation within Microsoft Excel.
- Ability to collaborate with quality, technology and operations counterparts on continuous improvement initiatives.
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 email@example.com.
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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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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Quality Operations
Job Title:Spclst, Quality
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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