Supervisor, Qa

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Clinical Trials Division (CTD) partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more. Our more than 3,000 employees in over 15 countries work hard every day knowing that what they do matters.

How you will make an impact:

We have an exciting opportunity for a Quality Assurance Supervisor to join the growing Mt. Prospect, IL site! This role will provide frontline oversight and leadership for the Quality Assurance functional area of Quality Operations. The QA Supervisor will help to drive a culture of Risk based quality, high employee engagement, collaboration, and flexibility. This role will collaborate cross functionally with the goal to influence appropriate quality and business outcomes and ensure processes are compliant with both company and regulatory standards.

Responsibilities:

• Applies cGMP in all areas of responsibility and follows all Thermo Fisher Standard operating procedures.
• Demonstrates and promotes the company vision. Drives team excellence by demonstrating and driving the Thermo Fisher values – Integrity, Intensity, Involvement and Innovation (The Four I’s).
• Leads and schedules Manufacturing QA staff in the inspection and auditing of packaging/manufacturing operations and Incoming Quality Control staff in the inspection of incoming materials.
  • Sets up the team for success by mentoring, building tools, directing resources, and supporting the team.
  • Owns success of the team by being accountable for their own actions and the team’s actions.
  • Manage supervisor administrative duties (time clocks, PTO, reviews, 1-1s, etc.)
• Improves any process for which gaps are identified in packaging operations or Quality operations by updating procedures and processes within the document control system. Continually improves processes by periodically reviewing all aspects of packaging operations as related to quality, staging, reconciliation, in-process inspection, label control, etc.
• Own quality by working to prevent deviations with site partners (Operations, Receiving, Client Services) and conducting quality investigations into non-conformances and deviations. Making risk-based decisions with strong quality rational.
• Assures that issues potentially affecting quality/compliance are escalated and resolved in a timely manner to the attention of Management and/or Senior Management.
• Develops and directs Quality Assurance systems that will enhance and maintain products that meet quality specifications and standards.
• Completes QA tasks in accordance with site schedules, ensuring timely support of production and business needs.
• Gather, track, trend, and analyze metrics data to ensure team is successful and take action when needed.
• Lead, hire, train, develop, and coach the employees in their career development and role. Maintain information and metrics to provide feedback on performance.
• Completes the performance evaluation of QA including the identification of development needs.
• Other duties may be assigned to meet business need

Required Experience:

• Bachelor’s degree (B.A./B.S.) from a four-year college or university required.
• 3-5 years of experience in Pharmaceuticals or a related regulated industry. Must have a sound understanding of cGMP’s, SOP’s, and 21 CFR part 210 and 211.

• Requires excellent supervisory skills and leadership ability. Must be comfortable with decision-making on quality issues. Requires ability to multi-task and prioritize. Organizational skills are required in order to ensure team responsibilities are completed the right way in a timely manner.
• Strong collaboration and influencing skills with team building and development capabilities.
• Experience improving cGMP processes using sound quality/compliance logic and data.

• Work schedule, Monday through Thursday, 10 hours per day. Flexible hours and must be able to spend time on both QA shifts. Additional coverage on Friday and weekends (Saturday or Sunday) may be required.

• 25-50% Standing and walking on packaging floor in order to monitor room activities. The employee must occasionally lift and/or move up to 20 pounds.

• Vision requirements for this position:  Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or less), color vision, and the ability to adjust focus.

Preferred Qualifications:

• Preferred 1-2 years supervisory experience.
• Experience with multiple perspectives from any of the following areas: IP inspections (AQL and time based), MQA packaging floor responsibilities, and incoming quality control.
• Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, among others)
• Familiarity with packaging paperwork and process.

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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 global 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.

EEO/Reasonable Accommodation:

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

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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.