Patheon Sr. QA Associate, Quality Assurance & Continuous Improvement (QACI) - OFF SHIFT in St. Louis, Missouri

Job Descriptions:

Must be willing to work a 2nd or 3rd shift - hours may vary

This is a non-supervisory role, reporting to the Manager of QA & Continuous Improvement (QACI), which is a sub-group within Quality Assurance - Operations.

The QACI group members are essentially specialists in deviation prevention, QA on-the-floor representation, and deviation authoring and deviation investigation/resolution facilitation. They spend up to 80% of work hours in the manufacturing areas when production is on-going to supervise the manufacturing activities from a quality perspective and answer QA-relevant questions/provide QA input real-time. The QA on-the-floor representation also includes the near real-time review of batch records to find problems and eliminate them before they manifest as larger or unresolvable issues.

QACI personnel, therefore, are responsible for executing in relation to those objectives, as well as other QA on-the-floor actions which become necessary as part of daily manufacturing operations. Personnel are responsible for adhering to GMP standards of job performance including ensuring that training is current in all aspects. Personnel are expected to take the initiative to improve the quality of operations and to improve and maintain a quality culture in the suites in which they work on a daily basis. Timeliness, quality, and accuracy of the QACI personnel work must also meet requirements. Personnel also ensure deviations are initiated when appropriate.

The team functions also as the liaison between Production, Production Support, QA, QC, Facilities, Engineering, Metrology, Process Development, and other departments as necessary to succeed in the core mission. As part of this, the QACI team ensures all groups are cooperating and functioning together in the required capacity in order to resolve deviations.

  • Perform Quality Assurance on the Floor activities. This will include but not be limited to oversight and review of critical operations on the floor; on the floor review of batch records as they are executed; assist manufacturing with deviation initiation and format.

  • Identify and assist in facilitating compliance investigations. Offer insight and input for corrective and preventive actions. Identify, analyze, and communicate trends and perform root cause analysis as necessary.

  • Represent the needs and interests of the QACI function in interactions with other functional areas. The individuals in this group must be able to obtain buy-in and cooperation to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact

  • Represent the QA organization and serve as liaison with manufacturing and other departments on site. Contribute to continual process improvement by participating in meetings, seminars, and site projects as necessary.

  • Responsible for completing training tasks based upon a monitored curriculum.

Required Experience:

EDUCATION AND QUALIFICATIONS

  • BS/ BA in biology, biochemistry, chemistry or other science related field

  • A minimum of five (5) years of cGMP (or other highly regulated industry) experience

  • Fluent in managing batch record review for GMP manufacturing

  • Experience working in a clean room required.

  • Knowledge of Quality practices and cGMP regulations and other international health authority guidelines

  • Demonstrated ability to make quality decisions is required

  • Critical thinking with the ability to read, analyze, and interpret technical data required

  • Solid time management and organizational skills required.

  • Demonstrated history of collaboration and interdepartmental relationships

  • Strong Microsoft Office skills (especially Word and Excel)

  • Must be able to read, write, and communicate in English

  • Must be willing to work a 2nd or 3rd shift - hours may vary

Desired Skills

  • Previous QA on the floor experience is a plus

  • Direct experience of two years (2) with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred

  • Direct manufacturing experience is a plus

  • Experience in an investigational writing software system (TrackWise) is a plus

  • Tech transfer experience is a plus

  • Root cause analysis experience is a plus

PHYSICAL DEMANDS/FACTORS

  • Able to function in a dynamic atmosphere and balance multiple priorities simultaneously

  • Able to stand for long periods of time while observing processes

  • Able to flex work schedule for investigational purposes or to support meetings

  • Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods. Repetitive hand motions.

  • Good hearing and capable of specific vision (color, close, and peripheral)

  • Able to gown, wear PPE, and work successfully in a clean room environment

Keyword: QA on the Floor, cleanroom, root cause analysis

From: Patheon