Senior Specialist - Product Quality Manager, Quality Assurance

Date: Apr 20, 2019

Location: West Point, PA, US

Apply now »
Requisition ID: MAN006253

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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 


The QA Sr. Specialist is responsible for ensuring that all Merck/MSD products managed by Biologics Quality Operations External Manufacturing (BQOEM) are manufactured, packaged, tested, released for further processing, stored, and distributed in accordance with Merck/MSD expectations and all applicable regulatory requirements. 


This role has responsibility for providing product specific Quality Oversight of External Entities and ensures that effective and robust Quality Systems are in place to comply with required regulations, policies and guidelines governing activities at External Entity (EE) sites by means of risk-based quality oversight and on-site supervision, as appropriate. The PQM is responsible for BQOEM batch release for further processing by downstream site of all products manufactured at the External Entity site including cell banks, biologic drug intermediates, biologic drug substance and biologics drug products.


The PQM will support External Entity relationships with activities of increasing complexity, scope, and volume which can be influenced by one or more of the following: number of products manufactured, number of sites supported, production volumes, number and complexity of markets, historical performance (production and compliance), new product or market launches, historical relationship between Merck and the External Entity, and manufacturing process complexity.


Primary Activities:

  • Evaluate and/or release products to downstream sites for further processing with the assurance that the goods were produced in conformance to all applicable policies/procedures of Merck/MSD and compliance with all governing regulations; review and approve changes to master batch records or laboratory methods/ specifications.
  • Manage routine and complex deviations, coordinate the investigation of customer complaints, and assist in the coordination of significant investigations, Fact Findings and product recall involving the EE as required.
  • Provide support for audits of the External Entity site by Merck/MSD and inspections by regulatory agencies.
  • Support analytical and process change control requests.
  • Oversee Stability Program management, including review of stability reports and quarterly reports
  • Prepare Annual Product Review.
  • Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.
  • Track and monitor operational and quality performance of the External Entity and work with site to develop CAPA plans as required for continuous improvement.
  • Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for transfer under quarantine.
  • Support routine process validation.
  • Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.
  • Regular site visits to build relationships and monitor efforts to improve the External Entity’s quality and reliability through ongoing oversight and formal communication programs and forums.

Qualifications

Education Minimum Requirement: 

  • Bachelor Degree in a Science, Engineering, or related areas of study.
Required Experience and Skills:
  • Minimum of 5 years’ relevant experience in the pharmaceutical industry and/or biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. 
  • Have demonstrated experience working in SAP.
  • Must have hands-on experience with change control process and deviations. 
  • Communicates in English, both verbally and in writing.  
  • Must have strong interpersonal, communication, negotiation, and persuasion skills to build strong relationships.
Preferred Experience and Skills:
  • Experience with biologic and/or vaccine Quality Assurance and Quality Control
  • Experience in Contract Manufacturing Oversight (CMOs, Labs, etc.)
  • Knowledge of common biologic and/or vaccine manufacturing processes
  • Experience with Trackwise change control application
  • Experience with COMET SAP for batch disposition, deviation management, CAPA management and PCR Trace

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

 

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.

  

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

            EEOC GINA Supplement 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Manuf./Operations Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 25 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
Company Trade Name: Merck


Nearest Major Market: Philadelphia

Apply now »