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. The Quality Specialist, with guidance from the IPT Quality Lead, ensures product / process quality and performs activities to review batch record documentation, facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system. The Quality Specialist also performs 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, effective investigation of deviations and support for change controls. Additionally, the Quality Specialist performs routine GMP walk through inspections of the shop floor within the assigned Focus Factory to ensure compliance with cGMPs and regulatory requirements.
The Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance, and will train on and gain competency in activities to facilitate release of product for assigned IPT. Job functions are performed primarily on the production shop floor and in a team environment. Specific responsibilities include but are not limited to the following:
- Performs batch release of products he or she supports.
- Collaborates with Plannng, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates
- Assists in sending samples/lab reagents to release authorities
- Completes required SAP transactions to release product in SAP
- Completes, reviews and sends release protocols to regualtory agencies.
- Performs 100% audit of process documents / log books to ensure completeness and accuracy for assigned IPT.
- Prioritizes document review to ensure alignment with product release due dates
- Maintains any tracking databases and logs associated with this review.
- Provides coaching and mentoring of manufacturing supervisors and operators completing documentation.
- Coordinates with Production to discuss, resolve, and eliminate documentation observations.
- Performs SAP transactions required to document Batch Recoird Review
- Performs GMP walk through inspections of assigned departments within the IPT to ensure compliance with cGMPs and regulatory requirements.
- Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material as required.
- Performs Quality review / approval of new and updated SOPs and CJAs.
- 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.
- Collaborates with IPT members to investigate deviations on production floor during shift.
- Works with necessary groups within the Focus Factory to resolve outstanding issues with process documents / log books, GMP walk through inspection observations and quarantine, management.
- Reviews Emergency Stamps / hand Stamps entered into the batch record.
- Performs Quality review of new and updated Master Batch Records.
Note: This is a first shift position.
Education Minimum Requirement:
- 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.
Required Experience and Skills:
- At least three years of relevant post-degree work experience in a laboratory, manufacturing, or quality position Or as a consultant providing support in one of these areas.
- 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 and attendant quality control problems.
- Basic understanding of cGMPs and of 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 and release of product is a key skill necessary for success in this position; prior batch record and release experience is a strong plus.
- Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is a strong 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC GINA Supplement
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
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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