Must be willing to work a 2nd Shift - 4p - 12:30a)
This role is as the Supervisor, Quality Assurance, Operations
The QA Operations group members are essentially specialists in deviation prevention, QA on-the-floor representation, minor deviation approval, batch record review and disposition. They spend approximately 50% 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 and 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.
The Supervisor, QA Operations, therefore, is responsible for supervising as well as performing the activities of the group in relation to those objectives, to train and develop, mentor and coach, the other team members of the QA group. The Supervisor is also responsible for ensuring that the team has all the tools necessary to properly function and must assertively represent his/her functional team in meetings and to ensure their interests and requirements are adequately cared for and looked after.
The Supervisor will ensure the team is adequately functioning as the liaison between Production, Production Support, QC, Facilities, Engineering, Metrology, Process Development, and other departments as necessary to succeed in the core mission. Also, the Supervisor will review and lead the work of the QA staff to ensure timeliness and quality of the work meets all requirements. The Supervisor’s work must also meet those requirements in order to demonstrate concrete metric reporting.
The Supervisor will mentor and train other QA team members. The Supervisor may participate in or assign and review the creation of portions of the manufacturing section for Annual Product Reviews.
ESSENTIAL JOB FUNCTIONS
- Responsible for completing training tasks based upon a monitored curriculum. Mentor and train QA team members.
- Identify, initiate, coordinate, and assist in compliance investigations as well as corrective and preventive actions. Identify, analyze, and communicate trends and perform root cause analysis. Track and perform trend analysis related to investigations, corrective actions, and effectiveness checks. Supervise the same from team members and ensure team members are meeting all standards of timeliness and quality.
- Partner with Manufacturing teams to ensure that regulatory commitments and requirements are reflected in daily activities.
- Represent the QA organization and serve as liaison with manufacturing and other departments on site. Participate in site projects and meetings (i.e. Quality Council, Change Control Board, etc). Contribute to continual process improvement by participating in meetings, seminars, and site projects.
- Represent the organization in internal audits and participate in external audits as a lead or sub team member. Write audit responses for internal audits related to manufacturing/ facilities.
- Perform Quality Assurance on the Floor activities, and ensure the timely and accurate performance of the same from team members. 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; ensuring that deviations are initiated as appropriate within the specified timeframe; ensuring initiated deviations contain the relevant, SOP-driven information required; development and maintenance of strong working relationships and partnerships with functional area personnel
EDUCATION AND QUALIFICATIONS
- BS/BA in biology, biochemistry, chemistry or other science related field or four-year degree combined with relevant experience.
- A minimum of five (5) years of cGMP (or other highly regulated industry) experience
- 3+ years of direct experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment
- Fluent in managing batch record review for GMP manufacturing
- Experience working in a clean room required.
- Previous supervision of staff
- Knowledge of 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 building teams 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 shift
- Previous QA on the floor experience is a plus
- Direct manufacturing experience is a plus
- Experience in investigational writing software system (TrackWise) is a plus
- Tech transfer experience is a plus
- Root cause analysis experience is a plus
- Able to lead productive cross functional meetings
- Able to learn and objectively assess technical processes
- Able to work in a rapidly changing climate; reacts well to change
- Able to work in both independent and team based environments
- Able to handle multiple tasks while remaining focused
- Able to understand written/verbal instructions (in English) and execute accurately and independently
- Plan, evaluate and prioritize individual and team assignments without direct supervision
- Present investigations/projects to upper management
- Represent team needs and interests to higher levels of management
- Proven ability to work with professional discretion on confidential information
Mentor team members and provide guidance and issue escalation in the absence of supervision
- Able to function in a dynamic atmosphere and balance multiple priorities simultaneously
- 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