What are the responsibilities and job description for the Training Specialist position at LSNE Contract Manufacturing?
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.
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. Provides administrative support for the OE Training SharePoint site and assists with process improvements related to Training and Operational Excellence initiatives.
Essential Job Functions-other Duties May Be Assigned
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.This job description may not list all activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or be assigned at any time with or without notice.
The hiring rate for this position is $26.73 - 30.07/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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.
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.
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. Provides administrative support for the OE Training SharePoint site and assists with process improvements related to Training and Operational Excellence initiatives.
Essential Job Functions-other Duties May Be Assigned
- 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.
- 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.
- 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
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.This job description may not list all activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or be assigned at any time with or without notice.
The hiring rate for this position is $26.73 - 30.07/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).
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.
Salary : $27 - $30