PCI Pharma Services · 19 hours ago
Quality Specialist Document Control
Philadelphia, PA
Full-time
Onsite
New Grad, Entry LevelPCI Pharma Services is a global leader in providing life-changing therapies and making a significant impact in the biopharma industry. The Quality Specialist Document Control is responsible for maintaining the Quality Management System, overseeing QA related documents, and ensuring compliance with documentation best practices across facilities.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
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 from creation/revision through approval, distribution, filing and retention of current and historical documents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
Qualification
Required
Strong interpersonal skills
Good Communication Skills-Written and verbal
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
Good Computer Skills. Knowledge of MS Office, Word, Excel, PowerPoint, Outlook; Visio; Access, Network – Imaginer); Performance aspects of position
Preferred
Basic knowledge of Lean Six Sigma and FDA cGMP's preferred
Experience in Pharmaceutical industry preferred
Experience in Printed industry preferred
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
Founded in 2012
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase