Senior Quality Assurance Specialist - GMP Manufacturing
Company: Lubrizol Corporation
Location: Bethlehem
Posted on: November 18, 2021
Job Description:
Lubrizol Life Sciences Health's CDMO business is the leading
CDMO for complex formulation development for the pharmaceutical
industry, with over 20 years of successful experience and a solid
base of clients ranging from the worlds largest pharmaceutical and
biotech companies to small VC backed start-ups. As a member of the
LLS Health team, you will be working for a company that is engaged
in important, exciting, and socially relevant projects. LLS Health
is a fast-paced environment that features a variety of projects,
technical challenges, and opportunities for growth. To learn more
about us, visit and .The Senior Quality Assurance Specialist is
responsible for ensuring compliant manufacturing activities
according to Good Manufacturing Practices (GMP), regulatory
guidance, and internal procedures. The Senior QA Specialist will
have oversight of daily processes and coordination of tasks within
QA and with the Manufacturing group to accomplish this goal; there,
excellent organization skills and the ability for open
communication is a must.Responsibilities include, but are not
limited to:
QA oversight during GMP manufacturing
processes and coordination of resources to accomplish this
taskCoordination with Manufacturing for QA availability and support
during manufacturingReview of batch records for completeness and
appropriate documentation techniqueReview of other manufacturing
documentation such as sampling plans, Master Formula Records, and
Master Batch Records for completeness.Oversight of GMP material
release and warehouse activities, including documentation and data
review. Issuance and reconciliation of all clinical
labelsAdministration ofthe retain program according to global
regulatory requirementsMinimum Qualifications:
- BA or BS degree in a scientific field
highly preferredAt least 7-10 years of related experience in
pharmaceutical industry, or equivalent combination of education and
experience with knowledge of current Good Manufacturing Practices
(cGMP). Experience with GMP manufacturing activities a
plus.Proficient with common PC-based applications, including
MicrosoftOffice
- Excellent verbal, written communication and organizational
skills & demonstrated independent analytical and problem-solving
abilities.
- Position will involve standing for extended periods of time and
minimal liftingLubrizol offers competitive benefits: Medical,
Dental, Vision, 401(k), Age-Weighted Defined Contribution Planand
so much more!Visit to learn more.Lubrizol Life ScienceHealth's CDMO
business is located in Bethlehem, PA, part of the Lehigh Valley
region of Pennsylvania. Lehigh Valley includes the cities of, and .
The region is slightly over an hour to both Philadelphia and New
York City, which places you right in the action. Buzzing with
business, culture, knowledge and entertainment, the Lehigh Valley
is a vibrant place for people of all ages and walks of life to
live, learn, work and play. This region offers a-
ethnically-diverse communities, affordable housing, award-winning
schools and universities, world-class healthcare, ski resorts,
museums, casinos, shopping, restaurants, sports and nightlife. From
the yearly festival, to skiing in the , to hiking or biking through
the many state parks, you can make it happen right here in the
.Lubrizol is an equal opportunity employer. Qualified applicants
will receive consideration for employment without regard to sex,
race, color, national origin, citizenship, age, religion, marital
status, military service, sexual orientation, genetic information,
gender identity, or any other characteristic or trait protected by
federal, state, or local law.Do You Need Assistance?Please let us
know if you need an accommodation to proceed with your application
for a posted job, or with any other aspect of the interview or
assessment process. You can either call 440-943-4200 and ask for
Talent Acquisition or send an email to
talentacquisition@lubrizol.com. Please note that this phone line
and email address are not to be used for checking on the status of
an already submitted application and not to be used by third party
recruiters.
Keywords: Lubrizol Corporation, Bethlehem , Senior Quality Assurance Specialist - GMP Manufacturing, Other , Bethlehem, Pennsylvania
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