Quality Systems Specialist (Biotech industry/ Labeling Change Requests experience) (part of Adecco) 3.8 3.8 out of 5 stars Irvine, CA 92618 • Hybrid work Hybrid position for a top Biotech company in Irvine, CA. 3 days onsite, 2 from home. 8am-5pm PST. This position will support the compilation and maintenance of IVDR technical files, review IVDR and other registration labeling change requests and various quality tasks to support the QMS overall. •No need for IVDR experience. The person will be assisting in reviewing and processing labeling change requests related to IVDR where he or she will match the supporting doc with the new labels. Other IVDR related activities will be similar where we already have a process in place. They should have just had quality related background or have done similar tasks or processes.

How You'll Make An Impact:

Review, approve, and process labeling and FOC change requests. Compile, create, review, and update quality related technical file documentations (i.e. DMR updates, compile finished product testing documents, etc). Various quality tasks such as LS FOC creation, non-labeling related change requests, etc.

What You Bring:

Education:

Bachelors degree preferred or high school diploma/equivalent with 2 to 3+ years of work experience.

Work Experience:

2+ years' experience in Quality, Documentation Control, Change Control process, GMP. Basic understanding of GMP and quality system standards. Proficient in Microsoft office (word, excel, etc). Detailed oriented with the ability to multi-task.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPA Job Types:

Full-time, Contract Pay:

$30.00 - $36.00 per hour Expected hours: 40 per week

Schedule:

Monday to Friday People with a criminal record are encouraged to apply

Work Location:

Hybrid remote in Irvine, CA 92618