Job Title-Compliance Specialist III

Location: Swiftwater, PA

Pay Rate: $35-40 per hour

Description:  

The Product Quality Batch Release (PQBR) Manager will perform the necessary activities to ensure compliance requirements and manufacturing/release schedules are met.  

Position Responsibilities:
o       Quality Review of Batch Records
o       Preparation & Certification of Working Documents
o       Quality Review of Lot Release Protocol (LRP)

o       Compliance and Performance

Technical Competencies:
o       Working knowledge of cGMPs and regulatory requirements
o       Knowledge of vaccines/biologics products and associated technologies
o       The ability to work on cross functional project teams
o       Meet/Exceed project timelines/deliverables
o       Experience with Quality Systems including: SAP, Quality eDoc,  LabWare, TrackWise and MS Office
o       Strength in several LEAD Competencies – Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
Soft Skills:
o       Communication
o       Interpersonal
o       Analytical
o       Negotiate/Influence
o       Organization
o       Detail Oriented
Basic Qualifications:
o       Bachelor’s degree
o       2+ years in a cGMP/ controlled, Quality environment in the pharmaceutical industry

Apply here