Job Description

　　As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

　　Location/Division Specific Information

　　Work Location: St. Louis, MO (on-site)

　　Group: Pharma Services Group

　　Division: Drug Substance Division

　　This role is as the Supervisor of Quality Assurance, Operations On the Floor (OTF) staff. This position is a second shift position with work hours from approximately 4:00PM - 12:00AM, typically Monday - Friday, however, there may be potential weekend work as needed.

　　How will you make an impact?

　　The QA Operations group members are specialists in deviation prevention, QA on-the-floor representation, minor deviation approval, batch record review and correction. 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 QA Operations Supervisor, 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 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 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 Review.

　　What will you do?

　　Provides leadership to assigned staff by performing the following: developing and empowering staff, cultivating relationships, putting staff in a position to succeed, achieving organizational goals, and driving engagement through creating a climate where staff are motivated to do their best.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/ facilitiesPerform Quality Assurance Batch Record Review activities on the manufacturing floor 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

　　How will you get here?

　　Education

　　Bachelor's Degree in Life Sciences (biology, chemistry, biochemistry) or other science related field.Non-science degrees will be considered with appropriate industry experience

　　Experience

　　5+ years of experience in Quality, Manufacturing, Engineering a cGMP or other highly regulated environment3+ years of experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environmentKnowledge of cGMP regulations and other international health authority guidelinesPrior supervisory experience of staff preferred.Demonstrated history of building teams and interdepartmental relationships

　　Knowledge, Skills and Abilities

　　cGMP experience and regulatory requirementsManufacturing experience is a plusCleanroom experience is a plusTech transfer experience is a plusRoot cause analysisAnalytical and critical thinking skillsStrong written and oral communication skillsStrong attention to detailSolid time management and organization skillsAble to manage difficult situations with tact and diplomacyExperience in investigational writing software system (TrackWise) is a plusPrevious QA on the floor experience is a plusLead productive cross functional meetingsLearn and objectively assess technical processesWork in a rapidly changing climate; reacts well to changePresent investigations/projects to upper managementRepresent team needs and interests to higher levels of managementMentor team members and provide guidance and issue escalation in the absence of supervision

　　Abilities

　　Able to function in a dynamic atmosphere and balance multiple priorities simultaneouslyAble to flex work schedule for investigational purposes or to support meetingsLifting < 50 lbs. Walking, sitting, focus on computer screen for long periods. Repetitive hand motions.Able to gown, wear PPE, and work successfully in a clean room environment

　　This position has not been approved for relocation assistance.

　　Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

　　Apply today! http://jobs.thermofisher.com

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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