Lead, Operations Training

Posted 5 Days Ago
Be an Early Applicant
America, AL
Junior
Pharmaceutical
The Role
The Lead, Operations Training role involves working with production leadership to uphold quality and safety compliance in the packaging process. Responsibilities include validating personnel's technical capabilities, providing onboarding training, updating training materials, and ensuring compliance with best practices and cGMP standards.
Summary Generated by Built In

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.

   

3rd shift:

Job Title: Lead, Operations Training

Department/Group: Production

Location: Assembly

Summary of Objective:

This position is required to work cooperatively with production leadership to uphold high standards for excellence and proper cGMP practices for packaging products, from beginning to end, according to quality and safety compliance, and customer specifications. This position will be the first introduction to the production floor processes and standards, and will need to have the ability to maintain strict performance expectations as defined in current PCI best practice documentation. Creation and revision of best practice training materials will also be an essential function of this role.

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.

  • Validate and certify the technical capabilities of production line personnel in accordance with the current standardized best practices, defined in company SOPs, Work Instructions, and batch record specifications.
  • Responsible for ensuring production line personnel are certified to the latest certification standards and established best practices.
  • Provide onboarding classroom instruction and training for new hire production floor personnel.
  • Integral team member for changes to current processes and implementations of new equipment. 
  • Prepares, updates and distributes appropriate training materials in coordination with production/training leadership.
  • Actively rotate and train on the floor to stay current with processes and maintain certifications.
  • Audit compliance and strictly uphold high standards of excellence during and after training/certification process.
  • Monitor training progression of individuals, and work closely with production management/supervisors to schedule training certifications.
  • Provide clear and constructive feedback to OJT trainers based on observations during certification.
  • Escalate all quality, service, and equipment performance issues to supervision. Promote and maintain a safe work environment.
  • Support 5S throughout the facility.
  • Ensure compliance to company policies and documented best practices. Maintain high levels of cGMP compliance and expect that all 5s principles are followed including material flow and min/max expectations.
  • Facilitate and drive prompt completion of company mandated and role specific Compliance Wire trainings.
  • Participate in regular feedback sessions and progress reviews with managers for continuous training process improvement.
  • Participate in all required professional development courses offered.
  • Perform other duties as assigned by Manager/Supervisor.
  • Attendance to work is an essential function of this position.

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.

Required:

  • Must be a minimum of Level 2 Line Leader to apply.
  • Consistent high performance in production floor processes and the use of current technology.
  • Basic Mathematical Skills
  • Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Proficiency in Microsoft Office Suite preferred.
  • Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
  • Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.

Preferred:

  • Ability to follow instructions and respond to management direction.
  • Ability to work independently and/or part of a team.
  • Ability to adapt to changing work environments.
  • Ability to demonstrate attention to detail.

For candidates in Illinois: The hiring rate for this position is $19.96-$22.46 hourly 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, Diversity, Equity, and Inclusion (DEI) 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.

The Company
HQ: Philadelphia, PA
2,259 Employees
On-site Workplace

What We Do

PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.

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