Specialist, Quality Systems
Company: West Pharmaceutical Services
Posted on: June 12, 2021
Working at West means having an opportunity to work by the side
of our patients and customers, our global team members and the
communities in which we operate - which all help contribute to a
At West, we are by the side of patients. The work we do impacts
patients' lives each and every day - our products are a critical
part of healthcare delivery and we are proud of the role we play to
improve patient health. We work by the side of our team members. We
come together as one global team to deliver for our customers and
help them address their challenges. We are a diverse, close-knit
community of professionals, where everyone has a voice and
opportunity to learn and grow through mutual trust and respect.
With a 95 year plus history, we have a track record for success,
which includes reported sales of $2.14B in 2020. We serve by the
side of our community. Giving back is in our DNA-our team members
across more than 50 sites globally are involved with hundreds of
charities that have special meaning to them through our West
Without Borders team member-led giving program.
This role is responsible for the coordination of the customer
notification process. Responsibilities include maintaining customer
notification records & documentation to demonstrate compliance to
regulations & requirements. This role will ensure customer
notifications regarding West's supplier changes maintain compliance
with West's procedures and policies. This role will also be
responsible for providing guidance, support, and training on West's
change control procedures and systems.
Essential Duties and Responsibilities:
- Performs activities for creation, issuance, and review of
customer notifications with focus on Medical Device related
- Coordinate customer notification process which includes direct
communication with change owners to define appropriate change
notification information, impacted customers and customer approval
process, if needed, with a focus on Medical Device and West
- Assist West Medical Device sites in preparation of global
change requests which includes documentation of change details and
ensuring harmonized approach of change implementation across like
- Coordinate activities of Change Control Review Board (CCRB) and
Medical Device Change Control Review Board (MDCCRB). This includes
facilitating cross functional team discussions and documentation of
meeting details and outcome.
- Maintain CCRB and MDCCRB metrics and customer notification
metrics for trending, analysis, and reporting.
- Participate in monthly change meetings with customers, as
applicable, to provide information on upcoming changes.
- Maintain the change control customer notification history,
records and documentation to demonstrate compliance to regulations
and company policies, procedures and requirements.
- Support initiatives for the development of digital strategies
to enhance change control and customer notification processes.
- Assist areas for training on change control and customer
notification procedures and key compliance requirements as applied
to West products and processes.
- Education: Bachelor or Master's degree in science preferred or
equivalent experience in related discipline
- Experience: Minimum 3 years of quality related experience with
preferred experience in Medical Device industry.
Preferred Knowledge, Skills and Abilities:
- Experience in regulated industry such as pharmaceutical and
- In depth knowledge of cGMP, cGDP, relevant ISO standards and
medical device requirements.
- Experience with SAP systems
- Familiarity with document management databases, particularly
- Approximately 5% travel, domestic and international, if
Physical & Mental Requirements:
- Excellent communication and interpersonal skills must be
coupled with public speaking, quick decision making
- Organizational skills will enable planning, prioritization &
achievement of goals especially of importance for the successful
execution of customer visits and business development related
- Position operates in a professional office environment. May
stand or sit for extended periods of time
- This role routinely uses standard office equipment such as
computers, phones, photocopiers, filing cabinets and fax
- Read and interpret data, information and documents
- Must maintain the ability to work well with others in a variety
- Must be able to multi-task, work under time constraints,
problem solve, and prioritize
- Ability to make independent and sound judgments
- Observe and interpret situations, analyze and solve
West is an equal opportunity employer and we value diversity at
our company. We do not discriminate on the basis of race, religion,
color, national origin, gender, sex, gender identity, sexual
orientation, age, marital status, veteran status, or disability
status. If you have a special need that requires accommodation in
order to apply to West, please send an email to
firstname.lastname@example.org. Where permitted by law, an offer of
employment with West Pharmaceutical Services, or any of its
subsidiary or affiliate companies, is contingent upon the
satisfactory completion of background screening and/or a
pre-employment drug screening.
Keywords: West Pharmaceutical Services, Wilmington , Specialist, Quality Systems, Other , Exton, Delaware
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