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Pharmaceutical Quality and Compliance Specialist
Ref No.: 18-33675
Location: West Point, Pennsylvania
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Medical Insurance
*1 year contract position with additional opportunity based upon performance and continued business need*

Quality Specialist – Biologics Quality Operations External Manufacturing (BQOEM)
 
West Point, PA is preferred location but open to other locations in NJ as well. 

Position Description

Responsible for ensuring that all Therapeutic Protein and Biological products managed by BQOEM are manufactured, packaged, analyzed, released stored and distributed in accordance with expectations and all applicable regulatory requirements. 
  • Ensures the Quality performance of external parties/partners through direct oversight, support and counselling to the partner’s Quality unit.  These activities include involvement in most aspects of external manufacturer operations related to the quality of products produced. 
  • The incumbent is responsible for the release of all manufactured products and to assure they have been produced from approved processes in conformance to all applicable regulatory requirements and Company policies. 
  • The incumbent exercises a leadership role in monitoring and maintaining Biologics External Manufacturing (BEM) compliance with the FDC Act, Current Good Manufacturing Practices Regulations (domestic and foreign) and other pertinent legal requirements.
Primary Activities
Possesses a combination of analytical/scientific skills in order to effectively manage and control all activities necessary to support a total Quality Operations program governing external parties/partners that manufacture, package, analyze, release, store and/or distribute Therapeutic Protein and Biological products. Receives guidance on policy issues as well as general and specific direction with regard to operations from the BQOEM Associate Director or BQOEM Director. 
For example:
  • Assures compliance with established policies/procedures of MMD and Corporation and complies with all applicable governmental regulations (GMP, etc.), both domestic and foreign.
  • Operates in a safe and efficient manner and in compliance with the MMD QO Safety and Health Policy.
  • Supports the development and maintenance of a Quality Agreement with the external parties/partners.  May provide input into the development of contractual agreements with the external manufacturers.
  • Reviews all audit outcomes pertaining to external manufacturers and ensures appropriate and timely corrective actions where warranted.
  • Acts in conjunction with the Director of BQOEM as the Merck Quality Operations point of contact to the external manufacturers.  Responsible for coordination, oversight, and communication on matters related to the GMP status of the external manufacturer.  Must be conversant with applicable regulations and compendia (domestic and foreign) governing the external party/partner’s operations.
  • Closely collaborates with appropriate business/operations and technical areas to achieve MMD objectives.
  • Acts as the Quality point of contact for the external party/partner and the liaison for contact and communications between the external party/partner and internal personnel.
  • Exercises a program of calibrated Quality oversight based on the product type as well as the capabilities, quality and compliance performance of the external party/partner.
  • Tracks and monitors operational and quality performance of the external party/partner. Monitors efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.
  • Works with the external party/partner to ensure that effective and robust Quality systems and Quality management are in place. Provides on-site guidance in the preparation of metrics, procedures, and guidelines where warranted.  Provides proactive support in training and coaching to implement quality improvements.
  • Provides guidance to the partner on conducting investigations of batch rejection, atypical events, customer complaints, etc. where warranted.
  • Responsible for evaluation and/or release of products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
  • In conjunction with other internal departments ensures that validation expectations are met, and external partners/parties are inspection ready for all new product introductions/transfers.
  • May act as a regulatory compliance liaison on Merck’sthe company's behalf to interface with regulatory Agencies. 
  • Assists in the coordination of significant investigations including Fact Findings.  Assists in the coordination of any product recall involving the external manufacturer.
  • Conducts quality due diligence assessments for pre-approval considerations of new external partners.  Supports the partner in remediation of due diligence and/or pre-contract audit gaps.
 
Position Qualifications: (please provide below)
Education Minimum Requirement:  BS degree (or equivalent) (Biology, Microbiology, Pharmacy, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering, etc.)

Required Experience and Skills:
Minimum of 5 years’ experience in the pharmaceutical industry with a thorough knowledge and broad experience of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements. Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills.  Communicates easily in English both verbally and in writing. Must have very strong relationship building skills. 

Preferred Experience and Skills:
Experience with biologic and/or vaccine Quality Assurance and Quality Control preferable.
Experience with SAP based MRP platform and TrackWise change control and customer complaint applications
Preferred some level of contractual and financial awareness.
 
Pay Rate: $50.50 per hour
Drug and background screenings required


On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.