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.
Main 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.
- Document Management and Control – Organize, scan, archive, and maintain R&D department documentation. Ensure document traceability, version control, template management, and compliance with internal procedures and GMP requirements.
- Documentation Issuance – Generate and issue forms, templates, labels, logbooks, and documentation associated with R&D trials, equipment runs, engineering batches, manufacturability studies, and pre-stability studies.
- Data Management and Reporting – Create, maintain, and update departmental databases and tracking tools using Smartsheet, Excel, and other systems. Compile data generated during trials and batches and prepare process charts, reports, and graphical trend analyses.
- Change Control Support – Coordinate and manage basic document-related change controls and support documentation updates in collaboration with project team members.
- Protocol and Report Preparation – Prepare simple protocols, reports, and controlled documents using approved templates and departmental standards.
- Production Data Collection and Analysis – Obtain and compile primary data from manufacturing equipment in accordance with cGMP requirements and internal PCI procedures. Generate process monitoring charts and supporting documentation.
- Training Administration – Monitor training compliance within the R&D department and support the creation, maintenance, and filing of training records.
- Personnel Administration – Support onboarding and offboarding activities for R&D personnel and maintain associated administrative records.
- Procurement and Shipment Coordination – Manage purchasing requests, monitor purchase orders, coordinate receipt of materials and samples, and organize R&D shipments, including samples and development materials.
- Continuous Improvement – Identify opportunities to improve documentation workflows, administrative processes, and departmental practices to enhance efficiency and compliance.
- Compliance – Maintain knowledge of and comply with all company policies, internal procedures, quality standards, safety requirements, and applicable cGMP regulations.
Work Experience and Skills Required
Essential
- Knowledge of current Good Manufacturing Practices (cGMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.
- Demonstrated ability to manage multiple administrative tasks simultaneously while maintaining a high level of accuracy and attention to detail.
- Strong organizational, communication, and interpersonal skills with the ability to interact effectively across multiple departments.
COMMUNICATIONS & CONTACTS:
- Works directly with R&D management, scientists, technicians, and project teams.
- Works closely with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing, and Project Management departments.
- Coordinates with internal stakeholders regarding documentation, training, materials, procurement activities, and change controls
- Ability to work independently and collaboratively within a multidisciplinary pharmaceutical development environment.
Qualifications:
Essential
- Associate Degree, Vocational Training, or Bachelor's Degree
- Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and database management tools such as Smartsheet.
- Honesty, integrity, respect and courtesy with all colleagues.
- Familiarity with cGMP documentation practices and document control systems is highly desirable.
- Creative with the ability to work with minimal supervision and balance with independent thinking.
- Resilient through operational and organizational change.
- Ability to work in a dynamic, fast-paced work environment.
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.
