QA Engineer II

Job Description

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day 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, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Thermo Fisher Scientific is making a significant investment in the dynamic and rapidly growing Cell Therapy space. Our Cell Therapy organization within the Advanced Therapy Business Unit, is one of the fastest growing areas of Thermo Fisher Scientific. We operate a 44,000-square-foot, innovative cell therapy collaboration center on the UCSF Mission Bay campus. Opened in 2023, the facility serves as a central location where customers and UCSF researchers will have access to Thermo Fisher Scientific's broad portfolio of solutions and clinical and commercial cGMP cell therapy manufacturing services, along with associated technology development support to our partners. In the Cell Therapy unit, we focus on providing development and clinical/commercial scale services for gene and non-gene modified cell processing for a variety of unmet medical needs.

The Quality Assurance (QA) Engineer with demonstrated experience driving and sustaining improvement to products, while ensuring that those products manufactured meet internal, customer, and regulatory requirements. The ideal candidate will strengthen our quality system, promote alignment to Quality Assurance policies and requirements, and drive the execution of quality goals and objectives.

What will you do?

Collaborate across functions, demonstrating quality and manufacturing expertise to address problems, interpret data, and determine next steps.

Support implementation of secondary suppliers and assist with the development of raw material specifications.

Participate in change control activities for documents and manufacturing processes.

Ensure accurate use of quality systems and processes.

Provide mentorship and direction to ensure ISO/Quality system compliance.

Spearhead maintenance, completeness, and accuracy of Quality records.

Lead problem requests (nonconformance's), complaint records, and corrective and preventive actions (CAPAs).

Build, review, and revise quality policies and procedures, and perform trainings when needed.

Review batch records in accordance with cGMP, including good documentation practices (GDP).

Ensure traceability to materials and equipment.

Generate Certificate of Analysis for finished good materials.

Identify and record any deviations related to a product's release; help process, and review deviations as needed.

Complete product release steps in our business systems.

Supports internal and external audits, including audit of batch records and release activities for cell therapy products.

Write, review, and revise Standard Operating Procedures (SOPs).

Perform change control activities for all document types, ensuring that the document control program meets all applicable standards and procedures and meets the required pace of business partners.

Support Vendor qualifications.

Identify and implement improvements using quality data, metrics, and Practical Process Improvement (PPI) tools.

How will you get here?

Education

Bachelor's degree in science or engineering, or related field is preferred. Equivalent education and experience can be substituted.

Experience

2+ years of relevant Quality/Manufacturing/Engineering or related experience.

Equivalent combinations of training and relevant work experience may be considered if at least a bachelor's degree is acquired.

Previous experience in a cGMP environment.

Previous experience in Cell Therapy is preferred.

Knowledge, Skills, Abilities

Proven track record to collaborate in multi-functional teams.

Demonstrated ability to conduct quality investigations including root cause analysis.

Strong verbal and written communication skills in English.

Solid understanding of cGMP practices.

Knowledge of regulatory guidelines: EU, US, ICH, etc.

Change control, Deviation and investigations, root cause analysis and risk assessment.

Experience with SAP, TrackWise, LIMS, EDMS is preferred.

Effective written, interpersonal, and presentation skills.

Proficiency in MS Office tools (e.g. Word, Excel, PowerPoint) and ability to learn new software programs.

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! ~~~

Benefits:

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension/retirement, 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.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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 ~~~*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The salary range estimated for this position based in California is $72,000.00-$108,000.00.

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: ~~~

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.