Description
JOB DESCRIPTION:- Partners with 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
- Provide oversight of labeling at 3PL
- Provide assessment of temperature monitoring system and coordinate release of incoming products based on assessment.
- Assists with assuring only released products get distributed to market.
- Assures proper material status (release, quarantine, hold, un-released, etc) is assigned to each lot.
- Assures materials are controlled (physically, electronically, and/or visually placarded) in accordance with their assigned control status.
- 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 personnel in topics related to quality or compliance.
- Contributes to the implementation, execution, and maintenance of the Quality Systems within the Logistic network.
- Assist with assessments of Quality Standards versus Logistics network SOPs.
- Participating on the Process Assessment Team
- Update Training Curriculums, training materials, as required.
- Assists with the review of Pest Control and Cleaning activities Logistics Network
Qualifications
- Associates degree in Biology or related field, 1-3 years previous experience within the Bio-pharmaceutical industry - preferably Quality and/or Compliance fields.
- Other skills and abilities required include but is not limited to: Quality and/or Compliance experience. Knowledge of pharmaceutical industry practices, boards of health regulations, CFR, cGMPs, compliance requirements.
- Excellent technical written and verbal communication skills
- Working knowledge of Computers required; also required is the ability to use Microsoft Office software programs (ie WORD, Excel, etc. )
- Personnel Interaction Skills
- Associate Degree, Logistics, Pharmaceutical, Standard Operating Procedures (SOPs)