QA Specialist I - 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.

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 < 10%

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

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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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled