QA Specialist I - Training
Company: PCI Pharma Services
Location: Bedford
Posted on: April 2, 2026
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Job Description:
Life changing therapies. Global impact. Bridge to thousands of
biopharma companies and their patients. We are PCI. Our investment
is in People who make an impact, drive progress and create a better
tomorrow. Our strategy includes building teams across our global
network to pioneer and shape the future of PCI. The Training
Specialist contributes to the maintenance, delivery and improvement
of the training program and courses to support all Cross Functional
GMP stakeholders across PCI. The primary objective of the Training
Specialist will be to focus on the delivery of the On-the-Job
Training program to support aseptic and non-aseptic manufacturing
operations. This position will play a key role in leading
functional and technical training including support of the building
of a robust training program to support the knowledge, skills and
qualifications of the PCI operators. Maintain GMP training
documentation to support personnel training needs via paper,
training databases and Quality Management System. Essential Duties
and Responsibilities: To perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The essential duties and responsibilities include
the following, but other duties may be assigned. Support the
manufacturing facilities and supporting functions for maintaining
training requirements and needs by providing guidance and
information on recommended training programs and providing routine
customer service. Deliver On-The Job Training as deemed appropriate
by management to support business needs and mentor trainees to
competent and confident performance of new tasks. Develop, maintain
and organize current and accurate training materials. This
includes: On the Job Training, learning activities, handouts,
checklists, worksheets, job aides and course evaluations and
performance Qualifications. Deliver and / or facilitate instructor
led training on GMP, technical skills, functional topics and others
as deemed appropriate by QA Management In conjunction with cross
functional stakeholders assist with performing training needs
assessment, develop courses and evaluations as assigned to support
the business. Manage Training requirements, events and tasks in the
eQMS (Master Control) for cross functional stakeholders. This may
include training assignments for new hires or transitioned
employees, new and revised documents or new programs. Determine the
impact of process changes to current training materials and propose
project plans to manage the updates. Assist with tracking of
qualifications and training metrics by generating training reports.
Writes and revises QA Standard Operating Procedures (SOP) under
minimal supervision Assists with training related actions
associated with delivery of training in support of Quality Events
(QEs). Perform other duties as assigned. Special Demands: The
physical demands described here are representative of those that
must be met by an employee to successfully perform the essential
functions of this job. The employee must be physically capable to
perform the duties listed below with or without reasonable
accommodations which may be made to enable individuals with
disabilities to perform the essential functions. Frequent reading,
writing, and verbal communication Must be able to travel between
multiple production facilities in close proximity Frequent Sitting
for meetings, computer work, etc. Ability to Stand, Lift, Bend,
Stoop and/or Kneel for the presentation and/or delivery of Training
(OJT) and/or Filing Work Environment: The work environment
characteristics described here are representative of those an
employee encounters while performing the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
Interacts with all departmental staff at various levels of the
organization, external clients and suppliers TRAVEL: Must be able
to travel between multiple production facilities, occasional out of
state travel possible Qualifications: The requirements listed below
are representative of the knowledge, skill, and/or ability required
for the stated position. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential
functions. 2 years of previous experience in GMP environment
Experience with GMP quality systems in a
pharmaceutical/biotech/medical device environment preferably
aseptic manufacturing environment. Experience working with
cross-functional teams and a results driven team player Ability to
multi-task in a dynamic environment with changing priorities
Bachelor’s Degree or equivalent related industry experience.
Preference to degrees related to science, adult education or
pharmaceutical processing. Basic eQMS/LMS system coordination,
administration and/or data entry skills, preference to Master
Control Instructional Design knowledge, e-Learning Development
capabilities and experience developing and delivering On The Job
Training and assessment materials. Highly knowledgeable and skilled
at pharmaceutical operations, including but not limited to:
gowning, aseptic practices, formulation, fill/finish. Proficiency
in MS Office including Word, Excel, Access and Visio Excellent
verbal and written communication skills required, ability to
present training content in a 1-1 setting or to a larger audience
Detail oriented, exceptional organizational skill LI-AK2 Join us
and be part of building the bridge between life changing therapies
and patients. Let’s talk future Equal Employment Opportunity (EEO)
Statement: PCI Pharma Services is an Equal Opportunity/Affirmative
Action Employer. We do not unlawfully discriminate on the basis of
race, color, religion, age, sex, creed, national origin, ancestry,
citizenship status, marital or domestic or civil union status,
familial status, affectional or sexual orientation, gender identity
or expression, genetics, disability, military eligibility or
veteran status, or any other protected status. At PCI, Equity and
Inclusion are at the core of our company’s purpose: Together,
delivering life-changing therapies. We are committed to cultivating
an inclusive workplace by holding ourselves accountable to the
highest standards of understanding, fairness, respect, and equal
opportunity – at every level. We envision a PCI community where
everyone can belong and grow, and we strive to bring this vision to
reality by continuously and intentionally assessing our people
practices, policies and programs, marketing approach, and workplace
culture.
Keywords: PCI Pharma Services, Lawrence , QA Specialist I - Training, Engineering , Bedford, Massachusetts
