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Thermo Fisher Scientific Quality Assurance Manager in Florence, South Carolina

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.

How you will make an impact

The Quality Assurance Manager will lead and manage all Quality activities at the site and associated storage areas used to manage materials for the products produced at the ThermoFisher API site. Provides leadership and guidance to the Quality team. This team executes manages the Quality System elements and ensures compliance to corporate and regulatory expectations. This team is critical to maintaining the site’s right-to-operate in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What you will do

  • Provide day to day leadership to Quality department staff. Create procedures to ensure compliance with current regulations and best practices.

  • Develop and implement systems for the review of batch documents, and work in conjunction with stakeholders to operate a synchronized business process that ensures that batch related production documents are prepared, reviewed, and compliant with ThermoFisher policies, procedures and standards.

  • Review/Approve Manufacturing Documents (Master Batch Records, Executed Batch Records, Cleaning Procedures, Variances, DCS Recipes, and BDR Specifications).

  • Analyze and assist with the resolution of existing/ potential quality related issues.

  • Oversee the discrepancy management process.

  • Review and provide approval of SOPs, EBR, MBR and controlled documents.

  • Establish goals for the Batch Review Group in partnership with Manufacturing, MSAT and Utilities and measuring and reporting group performance, and developing process improvements as necessary.

  • Work collaboratively with Manufacturing, Logistics, Quality Control and the EU Qualified Person in order to develop review criteria and lead times as products are introduced.

  • Participate on various project teams (Tech Transfer, Registration, Validation, Operations, and Inspections).

  • Prepare metrics for Qualification Validation, Quality Risk Management, Change Control, Batch Release, Investigations, and Discrepancies.

  • Prepare and Assist in the Writing of Procedures (Standard Operating Procedures, Equipment Operating Procedures, Department Procedures).

  • Perform batch release of intermediates and Site Finished Goods

  • Carry out managerial responsibilities in accordance with the organization's policies and applicable laws.

  • Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding, developing and disciplining employees; addressing complaints and resolving issues.

  • This position will staff, train and manage a group of QA associates and technical managers in order to perform the tasks in accordance with established standard lead times.

  • Administer, document and maintain the ThermoFisher Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of ThermoFisher Quality Systems and tools, as well as direct actions.

  • Deploying key metrics in the quality assurance processes and develop effective strategies to ensure continuous improvement and effectiveness of the quality system.

  • Perform other duties as required.

How you will get here

Education

  • Minimum of a BS in Chemistry, Life Sciences or related field required

Experience

  • Minimum of 10 years of pharmaceutical experience in a QA/QC leadership role, preferably with a plant manufacturing focus or an equivalent combination of education and experience.

  • Proven supervisory or management experience in a quality role and three to five years of batch review experience in support of GMP manufacturing preferred.

  • Knowledge of 21 CFR 110, 21 CFR 211, ICH Q7 and other regulatory standards governing the manufacture of bulk drug substance.

  • Demonstrated proficiency in interpretations of cGMP regulations, both US and international, SAP, and LIMS.

Knowledge, Skills, Abilities :

  • Must exhibit exemplary behaviors in line with ThermoFisher principles and values

  • Demonstrated ability to make quality decisions is required.

  • Demonstrated history of building teams and interdepartmental relationships

  • Critical thinking with the ability to read, analyze, and interpret technical data

  • Good planning and organizational skills

  • Ability to lead, train, motivate, and work within a team

  • Excellent oral and written interpersonal communication skills

  • Experience with data collection, data management analytics and KPI reporting

  • Understanding of risk management principles and ability to apply these principles in day to day Quality Management activities, quality and compliance issues and business challenges.

  • Strong Microsoft Office skills (especially Word and Excel)

  • Must be able to read, write, and communicate in English

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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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