Sr. Specialist, Quality Operations

  • Company: Merck
  • Location: West Point, Pennsylvania
  • Posted: January 13, 2017
  • Reference ID: QUA005282
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 Senior Quality Specialist, with guidance from the IPT Quality Operations Leader or Manager, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. He/she is responsible for ensuring adherence to Divisional, Company and Site policy, procedures and guidelines.

The Senior Quality Specialist position requires strong quality/analytical/scientific skills, as well as leadership abilities in order to manage Quality Operations (QO) within their team. Strong collaboration, communication, and decision making are attributes. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence.

  1. Acts as a primary QO contact for their area of support. As such, he/she must have sound knowledge of a wide variety of process, analytical, chemical, microbiological, instrument and automation disciplines associated with operations. He/she is accountable for the shared operations, quality and technology objectives for their area within the IPT, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time. Coordinates and executes all Quality Operations activities to ensure production plans are met, utilizing the tier process. Supports project work in the building.
  2. Manages aspects of the material control and/or release process as it relates to control of material for deviations and risk processing.
  3. Performs review and approval for investigations, CAPAs, QCTS commitments, change requests, risks, IQ/OQ/PQ, validation, Master Batch Records (MBRs), LIMS CRs, etc.
  4. Performs GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements.
  5. Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for the IPT. Supports the preparation of regulatory filings.
  6. Responsible for the review and release of intermediate or final bulk material for downstream formulation/filling for both domestic and international markets.
  7. Prepares and submits release protocols to CBER. Prepares CoAs to support regulatory filings.
  8. Write, review, approve SOPs and other instructional documents for shop floor.
  9. Provides training to incoming personnel and ensures compliance with departmental procedures.
  10. Performs duties of Quality Manager in his/her absence.

Education Minimum Requirement:
  • Bachelor's degree in a scientific or engineering field; candidates with majors in other fields may be considered if accompanied by sufficient relevant experience.
Required Experience and Skills:
  • Minimum (5) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, and/or Engineering
  • Strong understanding of cGMPs and regulatory requirements (domestic and international)
Preferred Experience and Skills:
  • Effectiveness and creativity in approaching and solving technical problems.
  • Proficiency in project planning and execution.
  • Strong verbal and written communication skills.
  • Aseptic/Sterile processing experience preferred.
  • Demonstrated leadership expertise working with cross-functional teams.

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
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 Poster
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