Senior Quality Assurance Technician

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-383384

Yoh is hiring for a Sr. Quality Assurance Technician
for our pharmaceutical client here in St. Louis, Missouri. The successful individual will assist with quality investigations in order to determine root cause and applicable CAPAs. Responsible for the thorough review of completed batch record documentation ensuring adherence to Good Documentation Practices, cGMPs and applicable local procedures. Perform assigned quality assurance activities in order to comply with applicable SOP's and cGMPs.

Schedule: Sunday - Wednesday 8am - 6:30pm

Essential Functions

• Ensure completion of require training, work (including document review, batch release, QA on-the-floor, AQLs), and timely release of materials and batches.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Responsible for the thorough and efficient review and disposition of completed batch record documentation ensuring adherence to Good Documentation Practices, cGMPs and applicable local procedures.
• Responsible for with dispositioning finished product, raw materials/ components and intermediates through an all-inclusive documentation review and cross reference of electronic quality systems.
• Responsible with release of incoming raw materials and components per applicable local procedures.
• This may include support for labeling dispositioned raw materials and components with appropriate status indicator labels.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety/Quality guidelines and SOP's.
• Ensure the maintenance of department, premises, and equipment.
• Ensure that all assigned training is carried out to competently perform assigned tasks confidently and consistently.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Collaborate with other team members to ensure assigned tasks are performed in a timely manner.
• Must demonstrate flexibility in adjusting to changing priorities and schedules.
• Attend mandatory trainings as required by site regulatory requirements and management.
• Assist with quality investigations in order to determine root cause and applicable CAPAs.
• Perform other general duties associated with the position as required by supervision.

• Bachelor Degree in life sciences or a related field preferred. Relevant work experience may be considered in lieu of degree.
• Three or more years of relevant experience required.
• Experience with computer data entry required, must be proficient in use of Microsoft suite office products.
• Must be able to analyze causes of interpersonal conflict and resolve complex communication issues (i.e., undefined roles, objectives, and information gaps).
• Experience with quality investigations in order to determine root cause and applicable CAPAs.
• Experience with US and international regulatory agencies and guidelines (i.e., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).