Training Specialist
Summary
Supports the development and delivery of training materials in collaboration with Subject Matter Experts (SMEs) and training stakeholders. Assists in implementing and executing training programs as required. Maintains training records and contributes to generating training metrics for review. Supports the training program’s compliance by assisting with regulatory and client audits.
Essential Job Functions
- Supports the development and delivery of training programs.
- Assists as a training liaison and resource to cGMP teams and committees.
- Contributes to continuous improvement initiatives across PCI Pharma.
- Tracks and monitors training milestones, meeting minutes, agendas, action items, and reports on KPIs and project status.
- Supports business improvement efforts and cost-saving initiatives.
- Assists with special projects, cross training, and other training-related needs.
Education and Experience
- Bachelor's degree (Life Sciences preferred): Master's degree preferred
- 4+ years of experience in Biopharmaceutical or similar industry
- Previous GMP experience required
- Prior experience with MasterControl or other eLMS systems preferred
Skills
- Ability to lead cross-functional teams
- Understanding of GMP guidelines within a Biopharmaceutical environment
- Exceptionally strong written, verbal and communication skills
- Ability to work independently, within prescribed guidelines, or as a team member
- Strong Microsoft Excel, PowerPoint, Visio, and Project skills
- Ability to work under pressure and multiple deadlines
- Understanding of Lean Six Sigma terminology and methods with Lean Six Sigma Green Belt or Black Belt training and certification preferred
- Computer Based training authoring experience (Captivate or Articulate) preferred
Work Environment
- Employee will work primarily in an office environment and occasionally in cGMP manufacturing cleanrooms.
- Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials.
- Employee will work with moderate noise level.
- Employee will perform tasks while experiencing numerous interruptions.
- The work environment is fast-paced and demanding.
- This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct.
- Off-shift, weekend and overtime duties may be required.
Pay and Benefits
- Hiring rate: $26.73 - 30.07/hour
- Eligibility for an annual performance bonus
- Benefits package includes: paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
About the Role
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO)
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.