Quality Specialist Document Control

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 Quality department is responsible for creating/maintaining the Quality Management System (QMS) for the Philadelphia facility. This Quality Management System includes Documentation Control, Investigation and CAPA Management, Training, Internal/External Audits, Customer Correspondence, Validation.

This position reports to the Senior Training Manager, and is responsible for all the upkeep, maintenance and control of all QA related documents. Such documents include SOP’s, forms, regulatory documents etc. Wherever possible, documentation best practices should be applied consistently across the facilities.

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.

• Responsible for maintaining the electronic SOPs and forms files on the shared drive.
• Responsible for maintaining the databases for SOPs and forms.
• Responsible for maintaining the SOP manuals and ensuring these manuals are always up to date.
• Responsible for batch record optimization. While this position is not responsible for the completion of batch records, they do have responsibility for ensuring that the batch record documents are optimized, consistent and managed effectively.
• Responsible for tracking and initiating periodic review of controlled QA documents (e.g. SOPs, forms, etc.).
• Works closely with the QA Business Units to ensure that documentation best practices are consistent with the QA systems landscape.
• Works closely with QA Director, QA Business Units and Operations Management. Responsible for the processing and tracking of controlled QA documents (e.g., SOPs, forms, etc.) from creation/revision through approval, distribution, filing and retention of current and historical documents.
• Provide timely and accurate reports and assessments of problems or potential problems to the Senior Training Manager.
• Assist with customer audits of the facility as required.
• Assist in preparing the site for inspection by regulatory authorities.
• Participate in regulatory inspections as required.
• Develop new Quality System procedures, and review and update existing procedures.
• Represent QA on project teams, management teams and other internal forums.
• Contribute to process improvement initiatives across the organization.
• Comply with Health, Safety & Environmental responsibilities for the position.
• Other responsibilities as assigned.

EDUCATION AND/OR EXPERIENCE:

• Strong interpersonal skills.
• Basic knowledge of Lean Six Sigma and FDA cGMP’s preferred.
• Experience in Pharmaceutical industry preferred.
• Experience in Printed industry preferred.

LANGUAGE SKILLS:

• Good Communication Skills-Written and verbal.

KNOWLEDGE/SKILLS REQUIREMENTS:

• Communication Skills: Written, Oral, Presentation, Candid, and direct feedback.
• Technical Skills: Computer Literate (Microsoft Office – Word, Excel, PowerPoint, Outlook; Visio; Access, Network – Imaginer); Performance aspects of position.
• Analytical Skills: Situation Appraisal; Problem Analysis; Decision Analysis; Potential Problem/Opportunity Analysis; Statistical Analysis.
• Interpersonal Skills: Able to work in a team environment.
• Quality Awareness: Quality System ISO; Statistical Process Control; Continuous Improvement, cGMP’s.
• Diversity / Multi-Cultural Work Environment.

COMPUTER SKILLS:

Good Computer Skills. Knowledge of MS Office, Word, Excel, PowerPoint, Outlook; Visio; Access, Network – Imaginer); Performance aspects of position.

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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.