Manager, Quality Operations Job

Employer
Merck
Location
Danville, PA, US
Posted
October 12 2017
Discipline
Other
Organization Type
Pharma
Requisition ID: QUA006280

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. 



 

Under the supervision
of the Quality Associate Director / Director, the Manager’s responsibilities
include but are not limited to: 



  • Overseeing laboratory
    technicians in performing wet chemical, instrumental, microbiological and
    physical analyses of in-process, intermediates and finished goods, raw
    materials, water and waste treatment samples.
  • Primary responsibilities
    will be the In-Process laboratory where they will be required to work a
    rotating shift schedule to support 24-hour operations. 
  • Ensures compliance with
    GMP/GLP, and quality, safety and environmental policies and procedures.
     
  • Ensures documentation is
    accurately completed and properly reviewed.
  • May perform project work as
    assigned by the Quality Associate Director / Director.  
  • Oversees all testing
    activities within the laboratory section of their responsibility. Ensures all
    associated documentation is completed in a timely and compliant manner. 
  • Ensures effective and
    timely deviation investigation closure; including, accurate root cause
    determination and implementation of effective solutions to prevent recurrences.
  • Ensures compliance
    with quality, safety, and environmental policies and procedures. Ensures the
    laboratory area is maintained in good order at all times and follows up to
    ensure compliance issues are remediated.
  • Ensures all members
    of the group are properly trained. Ensures all mandatory compliance and SOP
    training is completed in a timely manner and follows-up to ensure make-up
    training is received when necessary.
  • Participates in the
    hiring/section process for new technicians.
  • Ensures supplies and
    equipment needs are monitored and orders additional when necessary. 
  • Ensures appropriate
    maintenance of lab facilities by issuing and following up on work orders.
  • Serves as System
    Administrator for various instrument systems and ensures appropriate
    documentation is maintained consistently with compliance requirements.
  • May be involved in
    writing protocols and execution of method validations and transfers, stability
    studies, and equipment/instrument Qualifications. Responsible for conducting
    and documenting results from analytical investigations in memo form.
  • Knowledgeable in the
    Positive Performance Policies and manages employee performance, including
    adherence to work rules, attendance, tardiness. Ensures appropriate recognition
    is made for good performance and when warranted disciplinary actions are taken
    as necessary.
  • Ensures teams focus
    on continuous improvement using formal improvement systems, techniques, and programs.
  • Places a strong
    emphasis on effective communication. Meets regularly with the immediate work
    group, Manager, and customers being supported.
  • Supports necessary
    aspects of internal GMP audits and monthly walk throughs.
  • Provides review and
    revision of departmental procedures and test methods to ensure clarity,
    accuracy and GMP compliance.




  • Qualifications

    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.




    Education Minimum Requirement:

    • Bachelor’s degree in
      Chemistry or equivalent science degree 


     

    Required Experience and Skills: 

    • A minimum 3 years’ experience
      in a GMP Quality manufacturing/laboratory environment.
    • Experience
      with/knowledge of laboratory instrumentation troubleshooting/repair techniques.
    • Must be able to
      provide effective technical direction and training as necessary within the
      section.
    • Possesses strong
      problem solving skills, strong interpersonal skills, and the ability to work
      independently and with minimal supervision.
    • Required to work with
      hazardous chemicals while wearing personal protective equipment.
    • Must be able to work
      in and around the manufacturing and laboratory areas associated with chemicals
      related to Beta Lactum antibiotics.
    • Required to work a
      rotating shift schedule to support 24 hour operations. This will include
      day/night shifts and weekend shifts.


    Preferred Experience and Skills:

    • Working knowledge of
      GMP's as they pertain to Active Pharmaceutical Ingredient manufacturing.
    • Prior
      supervisory/management experience in a laboratory environment


    If you need an accommodation for the application process
    please email us at 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 Operations
    Other Locations:
    Employee Status: Regular
    Travel: Yes, 10 % of the Time
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck

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