QA Specialist II - Training

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.

Job Details:

The Training Specialist II plays a key role in developing, delivering, and maintaining training programs that support GMP compliance and operational readiness across manufacturing and support functions. This role provides advanced training expertise, leads complex training initiatives, and partners with cross-functional stakeholders to ensure training programs are effective, current, and aligned with business needs. The Training Specialist II is expected to work with minimal supervision, demonstrate strong instructional design capability, and serve as a resource for both technical and GMP training.

Essential Duties & Responsibilities:

• Deliver and facilitate instructor led training on GMP, technical skills, functional topics, and other areas as assigned by QA Management.
• Provide advanced On the Job Training (OJT) support and mentor trainees to ensure competent, confident performance of new or complex tasks.
• Support training related actions associated with Quality System Events (QEs), including targeted retraining, documentation updates, and training effectiveness checks.
• Develop, maintain, and organize comprehensive training materials, including OJT guides, learning activities, handouts, checklists, worksheets, job aids, course evaluations, and performance qualifications.
• Apply instructional design principles to create engaging and effective learning content, including e‑learning modules and blended learning solutions.
• Conduct training needs assessments in collaboration with cross‑functional stakeholders and recommend appropriate training strategies.
• Evaluate the impact of process or procedural changes on training programs and propose project plans to update materials accordingly.
• Manage training requirements, events, and tasks in the eQMS (MasterControl), including assignments for new hires, role transitions, new or revised documents, and new program rollouts.
• Generate and analyze training reports to support tracking of qualifications, compliance metrics, and training effectiveness.
• Write and revise QA Standard Operating Procedures (SOPs) with minimal supervision.
• Ensure training programs meet regulatory, internal, and customer requirements.
• Serve as a training resource for manufacturing, quality, and support functions.
• Partner with SMEs, supervisors, and leadership to ensure training content is accurate, relevant, and aligned with operational needs.
• Participate in cross‑functional projects that impact training programs, documentation, or competency requirements.
• Perform other duties as assigned.

PROFESSIONAL SKILLS

• Exceptional organizational skills and attention to detail

• Ability to make risk based decisions and resolve issues with minimal guidance

• Excellent interpersonal skills and the ability to communicate well orally and in writing

• Proficiency in MS Office including Word, Excel, Access and Visio

• Excellent verbal and written communication skills required

QUALITIES

• Ability to work in a dynamic, fast paced work environment

• Honesty, integrity, respect and courtesy with all colleagues 

• Creative with the ability to work with minimal supervision and balanced with independent thinking

• Resilient through operational and organizational change

Qualifications

• Bachelor’s Degree or equivalent related industry experience, preferred.

• Minimum of two years previous experience in GMP environment and 5-10 years of training experience.

• 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

• Preference to degrees related to science, adult education or pharmaceutical processing.

• Proficient 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.

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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.