Job Description

　　At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

　　Incredible Benefits!

　　Medical, Dental, and Vision - effective day 1

　　Paid time off and holidays

　　401k company match up to 6%

　　Tuition Reimbursement - available after 90 days

　　Employee referral bonus

　　Employee discount program

　　Employee recognition program

　　Charitable gift matching

　　Company paid parental leave

　　Career advancement opportunities

　　Location/Division Specific Information

　　Florence, SC

　　Pharmaceutical Services Group - Active Ingredients Product (API's)

　　Discover Impactful Work:

　　Support colleagues by providing direct quality support to the business unit. Performs quality functions to ensure accurate and timely completion with decision making, coordination and communications required. Reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, provides recommendations to others and implement solutions to resolve quality and efficiency issues. Implements systems to ensure compliance with new and changed regulations. Performs activities across quality functions to support the business units.

　　What will you do?

　　Lead, develop, and mentor a team of Quality Assurance staff that works in the manufacturing areas when production is on-going. This team oversees activities from a quality perspective and answers QA-relevant questions / provide QA input in real-time to support 24/7 GMP operations.Participate in daily operations review to provide feedback to departments on quality related issues and help in prioritization of tasks to ensure issues are taken care of in a timely, compliant manor.Serve as QA approver for deviations, batch record revisions, SOP revisions, and other required site documentation. In addition, supervise team members who also complete these tasks.Provide oversight of the preparation of batch disposition documentation.Individuals in your group must be able to obtain agreement and collaboration to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact and diplomacy with internal and external customers is essential.Supervise team by ensuring that routine meetings are held to keep team abreast of personal performance, team metrics, and site priorities.Provide Quality input to product-related investigations, deviations, change controls, and SOPs.Collaborate with clients by assisting with addressing their questions and concerns as they relate to quality oversite of operations.Provide quality system training to the organization, as needed.Participate in audits and inspections performed by clients and Health Authorities, as needed.

　　Education

　　Bachelor's degree in Science, Engineering or related field preferred.

　　Experience

　　Minimum of 5 years of pharmaceutical experience in a QA/QC leadership role, preferably with a plant manufacturing focus or an equivalent combination of education and experience. Supervisory experience 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.Previous project management experience is a plusExperience managing external customers is a plusDirect manufacturing experience is a plus

　　Tech transfer experience is a plus

　　Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

　　Knowledge, Skills, Abilities

　　Strong understanding of quality and regulatory requirements in the pharmaceutical (API) industry, including pharmaceutical GMPs, FDA regulations and current Good Documentation Practices (cGDP).Works on issues of moderate to high complexity in regards to compliance of processes and product within quality & regulatory compliance and data integrity.Knowledge in process improvement tools and implementation (Six Sigma, Lean Manufacturing, Risk Assessment, Root Cause analysis)Analytical and Quality approach.Ability to work in a fast paced environment, able to multi-task and results-oriented.Effective time management and prioritization skills and outstanding attention to details.Validated excellence in customer service skills.Excellent social skills to establish and maintain effective working relationships with internal and external customers.Highly effective communication verbal, written and presentation skills to high level management, customers, and employees, including technical writing skills. Proficiency in English LanguageProficient in the use of computerized systems and software (i.e. Outlook, Excel, Word, PowerPoint, Trackwise, SAP) and project management skills.

　　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.

　　Accessibility/Disability Access

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