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QA Supervisor - Cell Therapy (2nd Shift)

Company: Thermo Fisher Scientific
Location: Princeton
Posted on: November 23, 2021

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 will you make an impact*
The QA Supervisor (2nd Shift) is responsible for providing leadership by performing the following: developing and empowering colleagues; cultivating relationships; putting self and colleagues in a position to succeed, meeting personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where colleagues are motivated to do their best.
*What will you do* * Supervise and lead the QA department and all aspects of the people process including hiring, on-boarding, mentoring, coaching, annual objective setting, performance management and employee development
* Responsible for resource management and for initiating timely resource planning for the QA team based on production forecasts and business needs
* Provide QA oversight, technical expertise and leadership across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing and operations support
* Monitor and oversee the batch record review process, including escalation of issues and driving completion of quality records e.g. Deviations, Investigations, CAPA and Change Controls.
* Manage completion of GMP documentation to the required standard and timescales, to ensure timely and efficient service for our internal and external clients
* Prepare quality documents e.g. SOPs, technical documents, undertake investigations, review and approvals e.g. Change Controls, Deviations and Complaints
* Ensure new products, equipment and processes are effectively introduced to internal & external standards
* Proactively drive and react to system trending (e.g. deviations, complaints) to ensure ongoing quality performance.
* Act as QA SME during Regulatory Inspections and audits (e.g. client and corporate)
* Ensure own and teams KPI's, plans, targets and objectives are effectively monitored and achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and OTD/ OTIF
* Embrace and actively drive Practical Process Improvements (PPI) and performance by identifying opportunities to improve quality/compliance, reduce cycle time, reduce COGs, and increase operational efficiency. Partner with key stakeholders to prioritize projects aligning with the quality goals and objectives
* Ensure that own, and teams work complies with GMP, Data Integrity & Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP's, BMR's, Protocols, Guidance's, etc.
* Ensure own, and teams, training is undertaken in a timely and GMP compliant manner before the task is undertaken and maintain an updated and compliant training matrix for the team
* Maintain thorough understanding of international regulatory guidance, ISO, corporate and client requirements pertinent to the site, and to ensure that all work within the Quality department and across the aligned cell complies with these and with departmental procedures.
* Deliver effective leadership and communications in line with company rules, policies and procedures.
* Drives and owns "Quality on the Floor"-- - facilitating the desired "-- -way of working', quality culture and the 4i values through actions, coaching and mentoring.
How will you get here * BS/BA in biology, biochemistry, chemistry or other science related field
* 8+ years within a GMP Environment within Biologics and/or Cell/Gene Therapy pharmaceutical manufacturing preferred * 5 + years of experience within a Quality Role
* 1-2 years in a People Leadership/Management role preferred
* Proficient with computers (MS Office). Working knowledge of controlled documentation and data systems.
* In depth knowledge of cGMP regulations and product lifecycle.
* Knowledgeable of FDA/EMA regulatory requirements applicable to biologics, cell/gene therapy, or pharmaceuticals.
* Ability to apply GMP regulations and other international guidelines to all aspects of the position.
* Demonstrated ability to make key decisions.
* Technical writing skills.
* Technical knowledge of biopharmaceutical manufacturing and cell/gene therapy is desirable.
* Microsoft Project/Project Management is desirable.
* Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.
* Ability to aseptically gown and/or sterile gown as needed
* Ability to work within environmental clean rooms
* Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
At Thermo Fisher Scientific, each one of our 80,000 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.

Keywords: Thermo Fisher Scientific, Trenton , QA Supervisor - Cell Therapy (2nd Shift), Hospitality & Tourism , Princeton, New Jersey

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