This project has been archived and is not accepting more applications.
Browse open projects on our
job board.
Keywords
Description
Partners with LC Quality Operations colleagues to ensure compliance with all applicable Company Policies, Regulatory requirements, and industry practices. Performs functions associated with maintaining correct lot status within the Warehouse Management System
o Assists with assuring only released products get distributed to market.
o Assures proper material status (release, quarantine, hold, un-released, etc) is assigned to each lot
o Assures materials are controlled (physically, electronically, and/or visually placarded) in accordance with their assigned control status.
o Assures that changes to Material Statuses that are communicated from the manufacturing plants are applied to the materials in Real Time. Assists with training for the LC personnel in topics related to quality or compliance. Contributes to the implementation, execution, and maintenance of the Quality Systems within the PAH Logistic network.. Assists with assuring the robustness and compliance of Quality Systems: Plateau, PDOCS Cold Chain Manager, Rees, deviation tracking/trending and quality commitments. Assist with assessments of Quality Standards versus PAH Logistics network SOPs. Review/Approval of SOPs/Forms/Job Aids. Participating on the Process Assessment Team (PAT) Assists with review/monitoring of Calibration and Maintenance programs in PAH Logistics Network. Update Training Curriculums, training materials, as required. Assists with the review of Pest Control and Cleaning activities PAH Logistics Network Assists LC Quality Operations with self assessments, external Supplier audits, and Regulatory agency inspections as directed Bachelors degree in Biology or related field, 2-4 years previous experience within the Bio-pharmaceutical or Animal Husbandry industry - preferably within the Quality and/or Compliance fields.
Other skills and abilities required include but is not limited to:
o Quality and/or Compliance experience.
o Knowledge of pharmaceutical industry practices, boards of health regulations, CFR, cGMPs, compliance requirements, and quality standards.
o Excellent technical written and verbal communication skills
o Working knowledge of Computers required; also required is the ability to use Microsoft Office software programs (ie WORD, Excel, etc. )
o Personnel Interaction Skills
SKILLS
MS Outlook, MS Word
Synectics is an Equal Opportunity Employer.
