Manager, QC

Job Description

When your 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. We strive to bring together and develop extraordinary colleagues who share our passion for making significant contributions to the world.

At Thermo Fisher Scientific, each one of our 100,000 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.

Quality Control and Quality Assurance Manager

Position Summary:

You will be able to supervise all aspects of testing for site including EM and utility monitoring, growth promotion, microbiological identification, sterility, bioburden and endotoxin and analytical testing for raw materials, semi-finished and finished good disposition. Model our 4i values, integrity. Innovation, intensity, and involvement. Follow our Quality Policy by continuously improving the quality of our products & services and by ensuring global regulatory compliance. Follow the Thermo Fisher Scientific corporate standards, and best management practice.

Location/Division Specific Information

Location: Miami, Fl Site / Biologicals and Chemicals Division

Hours: Day Shift, Monday – Friday

About your responsibilities:

• Responsible for full incoming Quality Control of materials through to batch record review and release.
• Assists with helping to prioritize workload and assigning testing, ensuring effective daily operation of the department.
• Participates in the review of data reports results and completes all required documentation and electronic system entries.
• Accountable for accurate and timely completion of activities related to testing and projects.
• Performs test method validation and transfer, as required.
• Assists In documentation writing & revising, including test methods, product specifications, SOPs, etc. as required.
• Analyses and implements improvements related to QC processes and procedures,
• Performs troubleshooting and offers corrective recommendations for others within the team or for customer feedback purposes.
• Responsible for developing and evaluating department associates and may assist in the selection of new associates to ensure the efficient operation of the function. This includes all QC Microbiology and Chemical Analytical staff are trained and developed appropriately.
• Provides supervision to Quality Control associates on day-to-day activities of Quality control laboratory, schedule tasks and monitors completion of assigned tasks,
• Communicates with other group departments, and/or external customers within area of responsibility.
• Maintains working knowledge of current QC standard operating procedures (SOPs}, scientific literature, and new technologies, theories, and principles within area of scientific field.
• Responsible for training other staff.
• Ensures that timely, accurate, qualified and cost-effective testing is performed on: Raw Materials, In-process Materials, Finished Goods and Procured Finished Goods.
• Leads and ensure compliance of the Quality systems assigned: Quality Control System, Quality Inspections and supports Stability Program.
• Perform all job duties within regulatory or statutory requirements.

Your Education and Experience

• A Bachelor in Life Sciences or Engineering.
• Minimum 10 years of Pharmaceutical / Medical Device experience, including progressive supervisory/ managerial experience.
• Experience in facilities/utilities, product transfers, site expansion projects.
• Lean Six Sigma experience required. Certified Six Sigma preferred.
• Solid understanding base in all aspects of Lab testing, Quality Management Systems including quality control.
• Solid understanding of quality system regulations/requirements (i.e., ISO 9001:2000, 21 CFR Part 211/ 210, Part 601/610, Part 1271, Part 820 and cGMP/GLP and USP, EPA regulations).
• Working experience in the following systems: LIMS, EMPower, Chromeleon
• Should also be able to write and understand technically related protocols.

Your Knowledge Skills and Abilities

• Ability to work in a matrix environment, using influence.
• Strong written and verbal communication skills with ability to relate across all levels of the organization.
• Effective skills in analytical thinking and problem solving.
• Ability to lead teams to obtain results, self-motivated/advised, ability to prioritize activities, minimal direction required.
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Strong in application of technical principles, practices, and procedures.
• Ability to perform multiple tasks and ability to optimally manage conflict.
• Proficiency in Microsoft Office and statistical programs (i.e., Minitab, SAS)
• Strong in application of technical principles, practices, and procedures.

• Excellent Benefits Package

• Review our company’s Total Rewards
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Holidays
• 401K Company Match up to 6%
• Tuition Reimbursement – eligible after 90 days!
• Employee Referral Bonus
• Employee Discount Program
• Recognition Program
• Charitable Gift Matching
• Company Paid Parental Leave
• Career Advancement Opportunities

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.