Work Schedule
10 hr shift/nights
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Supervisor, Quality Control
When you're part of the team at Thermo Fisher Scientific (TFS), 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
We have industry leading sterile injectable facilities providing solutions to take product from Pre-Clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, and injectables.
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Hours
This is a third shift role, 10 hour shifts Tues-Fri 6pm-4am (this includes on call support on rotating basis over weekend).
How to make an impact on the TFS team
Provide technical leadership and Quality oversight in association with specific aspects of Environmental Monitoring (EM) to ensure compliance with regulations that govern pharmaceuticals. Establish actions and implement systems to achieve process improvements and efficiencies to address shortcomings. As Supervisor, offer assistance in problem-solving, failure analysis, and quality or process system design activities. Implement approved changes to policies and procedures in collaboration with labs, production, regulatory, quality, and clients. Engage your team in keeping safety in forefront. Thermo Fisher is an equal opportunity employer.
How to contribute to the team
Independently review and audit EM documentation and investigation report discrepancies and coordinate corrections/revisions. Coordinate your staff on day-to-day operations of multiple quality operations and assist with audits and regulatory inspections.
Conduct risk assessments with a cross-functional team and take appropriate actions to ensure adequate controls in relation to the level of product quality, safety, and business risks.
Provide oversight in the review/approval of EM records and data, as well as helping to meet goals for batch dispositions, assessment, investigations and validation projects. Evaluate protocols, procedures, and results for scientific and/or business merit.
How will you get here?
Education/Experience
- BS/BA in applicable scientific field with four (4) years confirmed experience (preferred) to include two years of leadership experience; OR
- AA/AS degree in applicable scientific field with five (5) years confirmed experience, including two years leadership; OR
- Previous job history in applicable scientific field with seven (7) years confirmed experience, including two years leadership
- Experience crafting basic training requirements, revising and writing Standard Operating Procedures (SOPs), and guidance documents
Knowledge, Skills, Abilities
- Knowledge of quality control statistics, documentation and adherence to SOP's.
- Knowledge of EM programs and all applicable phases including planning, testing, reporting and change control.
- Knowledge of aseptic processing in sterile environments and aseptic techniques/behaviors.
- Awareness of public standards and regulatory trends and their impact on cGMPs.
- Ability to coordinate with clients, regulatory reviewers and inspectors on issues to assure timely resolution of issues.
- Ability to sustain outstanding attention to detail and organizational skills, as well as recruit, train and develop staff.
- Ability to work in a fast paced environment and multi-task.
- Ability to collaborate with others to achieve team goals and expectations.
- Ability to write quality technical reports and give effective oral presentations.
Strengths You'll Need:
Put the Customer First - Think and act with a customer-centric approach to deliver outstanding customer experiences. Own Your Results - Take personal accountability for all you do and always exercise good judgement. Find a Better Way Every day - Be intellectually curious and adopt Practical Process Improvement (PPI).
We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!