summary

Perform independent oversight of Quality Control Investigations, guide multiple sites in performing Good Laboratory Practices and train Quality Control personnel as required. Responsible for ensuring the use of Good Laboratory Practices within the lab and implementing Quality Control Techniques training. Ensure adherence to FDA guidance by participating in site readiness for regulatory and external inspections.

essential Duties and Responsibilities

• Provide independent oversight on Quality Control Investigations (OOS/OOT/OOC/Lab incidents) to ensure compliance.
• Provide compliance and investigation training to QC personnel involved in investigations.
• Perform Quality Control Laboratory walk-throughs, observe practices, and provide feedback.
• Provide training as required to include in the Critical Quality Training Program and Quality Control Techniques.
• Identify emerging trends and specific areas in need of improvement.
• Support sites to enhance accuracy of Quality Control documents.
• Assist sites for readiness in regulatory and external inspections.
• Participate in meetings with management as required and provide updates on GLP compliance in the Quality Control lab.
• Participate in the development of new initiatives.
• Establish and monitor appropriate document turnaround time. 

KNOWLEDGE/SKILLS/ABILITIES

• Demonstrated thorough knowledge and understanding of Quality Control function and Good Laboratory Practices (GLP).
• PC proficiency using Microsoft Office required; LIMS and Trackwise a plus.
• Outstanding oral communication and conflict resolution skills with all levels of the organization.
• Ability to think critically and apply critical thinking processes to investigations, OOS and OOT data reviews.
• Highly organized and able to work comfortably with accelerated work pace.

EDUCATION/EXPERIENCE

• Bachelor's degree in the sciences or related technical field.
• Five years' experience in a Quality role that involves conducting review of investigations, changes and deviations, in-process checks in a pharmaceutical environment.
• A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.