Manager, Quality Operations Job
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
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
Under the supervision
of the Quality Associate Director / Director, the Manager’s responsibilities
include but are not limited to:
technicians in performing wet chemical, instrumental, microbiological and
physical analyses of in-process, intermediates and finished goods, raw
materials, water and waste treatment samples.
will be the In-Process laboratory where they will be required to work a
rotating shift schedule to support 24-hour operations.
GMP/GLP, and quality, safety and environmental policies and procedures.
accurately completed and properly reviewed.
assigned by the Quality Associate Director / Director.
activities within the laboratory section of their responsibility. Ensures all
associated documentation is completed in a timely and compliant manner.
timely deviation investigation closure; including, accurate root cause
determination and implementation of effective solutions to prevent recurrences.
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.
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.
hiring/section process for new technicians.
equipment needs are monitored and orders additional when necessary.
maintenance of lab facilities by issuing and following up on work orders.
Administrator for various instrument systems and ensures appropriate
documentation is maintained consistently with compliance requirements.
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.
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
on continuous improvement using formal improvement systems, techniques, and programs.
emphasis on effective communication. Meets regularly with the immediate work
group, Manager, and customers being supported.
aspects of internal GMP audits and monthly walk throughs.
revision of departmental procedures and test methods to ensure clarity,
accuracy and GMP compliance.
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
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.
with/knowledge of laboratory instrumentation troubleshooting/repair techniques.
- Must be able to
provide effective technical direction and training as necessary within the
- 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.
supervisory/management experience in a laboratory environment
If you need an accommodation for the application process
please email us at firstname.lastname@example.org.
Search Firm Representatives Please Read
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:
Job: Quality Operations
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck