This position reports to the Quality Assurance Supervisor. The role is responsible for performing quality activities in a sterile pharmaceutical manufacturing facility. The candidate should understand pharmaceutical cGMP requirements. The position requires an individual who works independently and in a team environment, with attention to detail, and maintains communication with other functional areas and sites.

This position is a six month temporary assignment.

What you'll do:

Responsible for performing daily quality functions including:

• Release all components, drug product containers, closures, packaging, labeling, in-process materials, and finished products.
• Monitor storage conditions of the manufacturing environment, materials, and products.
• Maintain document control through review, approval and issuance of SOPs, batch records, labels and other controlled documents.
• Review and retain all records associated with batch issuance, work instructions, release of product and all quality management data
• Review laboratory data of the finished drug product, environmental monitoring, microbiological testing, chemical testing, in-process testing and stability testing.
• Identify adverse trends and recommend improvements.
• Communicate with Production and Shipping/Receiving to ensure appropriate materials and supplies inventory are appropriately qualified, documented, and suitable for intended use in manufacturing.
• Investigate, review and trend deviations, OOS results and customer complaints.
• Support equipment calibration, equipment/utility/facility validation, and preventive maintenance.
• Participate in reviews of process qualification and product quality.
• Manual QMS, including document control of SOPs, batch records, controlled documents, training module, and all quality activities.

Who you are:

• Excellent written, verbal communication and presentation skills (preferred)
• Ability to adapt to changing priorities and circumstances
• Ability to think and act independently while knowing when to include others in decisions
• Ability to work in a dynamic, fast paced and timeline-driven environment with shifting priorities
• Strong understanding of Microsoft Office and Excel software
• Experience in investigating and writing customer complaints (preferred)
• Strong problem solving and decision making skills

Physical Requirements:

Must be able to stand for up to a 4-hour period (with break).

What you've done:

1+ years’ experience in a quality position at a cGMP facility. Fundamental knowledge of cGMP regulations as well as quality management systems. Knowledge of sterile injectable product in a pharmaceutical environment preferred. Food or cosmetic will be considered.

High School Diploma or equivalent. College diploma with focus on sciences preferred.

This position is temporary role for six months and not eligible for benefits.