Quality Coordinator

- 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.