Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that positively impacts a global scale. Join our colleagues in bringing our Mission to life daily to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, ensuring our food is safe, or helping find cures for cancer.
Discover Impactful Work:
This is an individual role, reporting to the Head of Cell Therapy Quality, a subgroup within the Quality Unit.
The Sr Quality Control Specialist oversees the Technology Transfer of methods for new products, ensuring the verification, qualification, and daily testing of methods in support of Manufacturing Operations. Equivalent experience and educational requirements, such as PD, are acceptable. The QC team is accountable for successfully executing customer-focused technology projects within the QC department. The Supervisor, QC Analytical, collaborates closely with supervisors, line management, clients, and (senior) scientists from Process Development (PD) and QA.
Develops and empowers colleagues, building effective teams that apply diverse skills and perspectives to achieve common goals. Encourages colleagues to meet personal career goals while also achieving interpersonal goals.
The QC Lead for our new cell therapy unit will exhibit leadership traits and be seen as a leader by their group and the site when Quality Control issues come up. They will ensure responsibilities are met and maintain a strong quality culture in the QC portions of the facility that is aligned with quality.
A Day in the Life:
This position will support the Network Quality and Site Leadership teams in delivering the following work:
Responsible for resource management and for initiating timely resource planning for the 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.
Responsible for the batch record review process, including customer concerns about issues and driving the completion of quality records, e.g., OOS, Deviations, Investigations, CAPA, and Change Controls.
Facilitate the desired 'way of working,' quality culture, and 4i values through actions, coaching, and mentoring to drive the team's quality mentality.
Lead 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, such as SOPs and technical documents; undertake investigations, reviews, and approvals, such as OOS, Change Controls, Deviations, and Complaints.
Proactively drive and react to system trending (e.g., deviations, complaints) to ensure ongoing quality performance.
Act as primary QC representative during Regulatory Inspections and audits (e.g., client and corporate).
Ensure plans, targets, and objectives are achieved, including standard lead times and supporting the Business goals, e.g., RFT and OTD/ OTIF.
Embrace and actively drive Practical Process Improvements (PPI) and performance by seeing opportunities to improve quality/compliance, reduce cycle time, reduce COGs, and increase operational efficiency-partner with key customers to prioritize projects that align with quality goals and objectives.
Align work with GMP, Data Integrity, and Good Documentation Practice (GDP). Adhere to quality documents like SOPs, MBRs, Protocols, and Mentorship.
Complete required training before starting tasks and keep an updated training matrix.
Keys to Success:
Education
A bachelor's degree in biochemistry, analytical chemistry, or a related field is required.
Experience
8+ years within a GMP Environment within Biologics and/or Cell/Gene Therapy pharmaceutical manufacturing (equivalent combinations of education, training, and relevant work experience may be considered).
2 + years of experience within a Quality Role, preferably as a people leader.
Knowledge of Lean labs.
Proficiency with personal computers, business software (e.g., MS Office), and technical software (e.g., Quality Management System (QMS) software), including software programs generating reports and statistics.
Ability to build, use, and interpret scientific tables, charts, and graphs.
Knowledge, Skills, Abilities
Knowledge of general and specific QC analytical testing principles is important for this position, particularly in the context of testing. This includes expertise in Flow Cytometry, Cell Counting, and ELISA.
Knowledge of testing and associated equipment protocols and requirements and analytical instrumentation.
Knowledgeable of FDA/EMA regulatory requirements applicable to biologics, cell/gene therapy, or pharmaceuticals.
Technical writing skills.
Actively take the lead in ensuring company GMP compliance. Set strategy in investigations and CAPAs, as necessary.
Participate and/or lead meetings, to provide input on timelines, potential compliance issues and other related QC activities.
Able to build and sustain highly functioning teams, cohesive, aspiring for shared and individual goals in a positive atmosphere for all employees. Able to coach and mentor more junior employees to success.
Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
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
Benefits!
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Compensation and Benefits
The salary range estimated for this position based in California is $112,500.00-$168,750.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
