Quality Coordinator

ROLE/RESPONSIBILITIES:
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.
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 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 (PAT).
Update Training Curriculums, training materials, as required.
Assists with the review of Pest Control and Cleaning activities.

SKILLS:

SKILLS/QUALIFICATIONS:
Associates degree in Biology or related field, 1-3 years previous experience within the Bio-pharmaceutical industry - preferably Quality and/or Compliance fields.
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
Ability to use Microsoft Office software programs (ie WORD, Excel, etc. )
Personnel Interaction Skills
Logistics
Pharmaceutical experience
Standard Operating Procedures (SOP's)