Manager, Quality Operations Job

Danville, PA, US
September 22 2017
Organization Type
Manager, Quality Operations-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

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:

- 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.


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
- 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

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:

EEOC Poster

EEOC GINA Supplement​

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

Job: Quality Operations

Job Title:Mgr, Quality

Primary Location: NA-US-PA-Danville

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 3

Shift (if applicable): Other (see Work Schedule)

Hazardous Materials: The site is a manufacturer of beta lactam antibiotics and, as a result, candidates must be able to work in and around the manufacturing and laboratory areas associated with such chemicals.

Company Trade Name:Merck

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