VBF QA Associate Specialist

Employer
Merck
Location
Durham, NC, US
Posted
April 12 2018
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA007202

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. 

 

GENERAL SUMMARY:

 

The Quality System and Compliance Associate Release Specialist is responsible for document review and release functions that supports Durham Varicella Bulk Facility. The Associate Release Specialist must adhere to regulatory, global and site policies and procedures governing product release.

 

GENERAL PROFILE:

  • Performs routine assignments in the entry level to a professional role
  • Requires knowledge and exposure to cGMP and GDP
  • Develops competence by performing applicable work assignments
  • Uses existing procedures to solve routine or standard problems
  • Receives instruction, guidance and direction from others
  • Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives

BUSINESS EXPERTISE:

  • Applies general knowledge of company business developed through education or past experience
  • Understands and applies regulatory/ compliance requirements relative to their role

FUNCTIONAL EXPERTISE:

  • Basic conceptual knowledge and practices associated with Document Review and Product Disposition
  • Essential Functions:
    • Review and approve Culture Media, Bulk Production, and Process Simulation batch records
    • Review and approve records from supplemental manufacturing operations through system reports and logs.
    • Work with Operations Technical Support Team and Coaches to resolve issues identified during document review
    • Coordinate, maintain, and close Risk Processing memos
    • Assist in investigations, which includes interactions with vendors or Merck's Supplier Development and Procurement Management for issues associated with raw materials and components
    • Approve batch notes entered into SAP
    • Present deviations at Event Notification meetings; as well as, perform product inventory control activities associated with the deviation.
    • Perform necessary SAP transactions to indicate task completions or stock status updates to support batch disposition decisions
    • Review and Release incoming components, including performing incoming inspections
    • Review and approve tests and results in LIMS
  • Additional Functions:
    • Participate in process improvement or learning events, as guided or approved by Quality management
    • Author and review SOPs
    • Direct support of regulatory inspections and audits, as requested
    • Direct support of validation activities and other associated Quality functions
    • Other duties as requested by Management

PROBLEM SOLVING:

  • Uses existing procedures to solve routine or standard problems
  • Applies limited judgment and discretion

INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:

  • Responds to standard requests from clients and/or customers

IMPACT:

  • Errors or lack of understanding of the job may cause delays in releasing material for use in Operations and to the end market
  • Influence and Decision Making:
  • Communicates information, asks questions and checks for understanding
  • Has limited decision-making authority; works within technical guidelines and direction to achieve objectives and meet deadlines

PROBLEM SOLVING:

  • Uses existing procedures to solve routine or standard problems
  • Applies limit

PROJECT MANAGEMENT:

  • Accountable for contribution to project team or sub-team

RESOURCE MANAGEMENT:

  • Builds awareness of costs related to own work

QUALIFICATIONS:

A. Essential:

  • Associate Degree in a scientific discipline with 5 years’ experience in Quality Assurance role or Bachelor’s Degree in Biology, Biochemistry, Chemistry or other relevant discipline

B. Preferred:

  •  Quality Control, Quality Assurance and/or cGMP experience

PHYSICAL REQUIREMENTS:

  •  Ability to sit, stand and move within work space for extended periods
  •  Ability to perform repetitive tasks

WORKING RELATIONSHIPS:

  • Reports to Manager, Quality Systems & Compliance (IPT Virus Support)
  • Interacts with employees within own department
  • Frequent interaction with employees from other departments
  • Interacts with representatives from regulatory agencies judgment and discretion
Qualifications

Education:

  • Associate Degree in scientific discipline with minimum 5 years’ experience or B.S., B.A., or M.S. degree in Science, Engineering, or equivalent experience

 

Required:

  • cGMP in pharmaceutical industry; ability to aseptically gown, previous QA experience; ability to work independently

 

Preferred Experience and Skills:

  • Three (3) or more years experience in the pharma industry, knowledge of CFR regulations, knowledge of environmental monitoring

 

 

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 



Job: Quality GMP Related
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

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