Job Description

Job Purpose

The STS Quality Specialist II will provide support for Document Control and Technical Writing; this position will support the Quality Management System for the Science and Technology Team facility in San Diego, CA.

Job Duties, Responsibilities and Authorities

The role has the following responsibilities and authorities as assigned by the Manager:

Responsible for efficiently processing Document Change Requests (DCRs), including routine data entry, coordinating document review/approval/release per department SOPs.

Use MasterControl to manage all document reviews and workflows.

Responsible for document writing and revision processes to be progressed in a timely manner by all parties; this requires strong communication, follow up and influencing skills.

Provide Technical Writing support through conducting Document Reviews and use practical laboratory scientific work experience and Technical Writing skills to revise technical SOPs; this requires strong time management, prioritization, and interpersonal skills to coordinate cross-functionally with scientists and Principal Investigators as well as excellent listening, interpreting, and writing skills.

Assist with revisions to Quality, Operations and EHS SOPs as needed. Assign Master Control job codes and training correctly. Participate in Internal Audits, and as an Internal Auditor. Support Quality Management System and Quality Department with other responsibilities as assigned.

Education & Experience

Bachelor’s degree is highly preferred, Associate/High School and/or combination of education and experience may be considered.

At least 2 years of scientific laboratory and/or manufacturing work experience required.

Prior work with document control in a GMP manufacturing environment is preferred.

Knowledge, Skills, Abilities

Experience with Master Control is preferred.

Experience managing Document Control system is preferred.

Technical and laboratory work experience is required.

Strong understanding of ISO 9001:2015 standard is required.

Work independently with minimal supervision and direction.

Ability to influence others and work cross-functionally.

Promote safe work habits and adheres to safety procedures and guidelines.

Strong planning, organization and multitasking skills.

Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.

Compensation and Benefits

The salary range estimated for this position based in California is $66,000.00–$99,000.00.

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: https://jobs.thermofisher.com/global/en/total-rewards

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.