Thermo Fisher Scientific Quality Specialist I in Canoga Park, California

Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location / Division

Canoga Park, CA / Transplant Diagnostics (TDX)

How will you make an impact?

The Quality Specialist I is responsible for efficiently processing Document Change Requests (DCRs), including routine data entry, coordinating document review/approval/release per department SOPs. Manage quality records, review and archiving process. As well as assist with label change requests as needed. Provide administrative support in accordance with departmental procedures. This position will ensure all records are maintained in a manner compliant with company policy.

What will you do?

· Regularly perform quality review of document changes requests, to include:

o Review of manufacturing, packaging, and laboratory documents for in-process and final document release

o Proficient initiation/coordination of document change requests and releasing of document change requests within Master Control in a timely manner

o Editing, formatting and final drafting of standard operating procedures

o Writing as well as assist others in writing new or updated operating procedures as needed

o Routine maintenance of active and archived controlled documents and records in accordance with department SOPs

o Coordinate the translation of all required documents

· Manage the “Document Change Request” mailbox on a daily basis

· In a timely and prompt manner, identifies, reports, and seeks correction for deviations noted in the workplace. He/she will practice all behaviors in a safe and environmentally responsible manner

· Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems

· Assist in document preparation for regulatory agency visits and Corporate/internal audits

· Report improvements to management and appropriate cross-functional teams

· Review of quality records for adherence to cGMP and GDP

· Assist in processing label change requests as assigned by the Quality Assurance Supervisor

· Provide real-time support for problem prevention/intervention and compliance improvement

· Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, The Quality Assurance Associate will ensure quality and compliance and safety in all their actions

· Adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed

· This position will keep confidential all laboratory data and business information, as well as maintain a cooperative and professional relationship with all OLI staff.

How will you get here?

Education

· Bachelor’s Degree from an accredited higher learning institution. In Life Sciences is preferred.

Experience

· 2 years of related QA or QC experience. In a GMP regulated environment is preferred.

Knowledge, Skills, Abilities

· Efficiently follows instructions

· Strong attention to detail and highly organized

· Excellent written and verbal communication skills

· Required to work effectively on cross functional teams

· Operate a computer terminal on a daily basis

· Occasional lifting of equipment of up to 35 pounds

This position is not currently budgeted for relocation.

At Thermo Fisher Scientific, each one of our 70,000 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.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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.