QC Technician - 21565Simply Biotech • Poway, CA, US
QC Technician - 21565
Simply Biotech • Poway, CA, US
23 hours ago
Job type
- Full-time
Job descriptionSupport Environmental Monitoring Program, including monitoring, trending, reporting, and coordination of EM validations. Management of Equipment Calibrations and OOT Response Management of Raw Material Program (Specification development, inspection, testing and release) QC testing (intermediate and final product release) Deviation Management including OOS, OOT, and associated investigations, and CAPAs, Sample management and tracking program Management of QC Record keeping and archiving Reporting and organization of Quality Control test results Issue batch records and labels Assist in review of completed records prior to filing in Records Management Maintain technical report and change control files Assist in deviation investigations and coordination of corrective and preventive actions (CAPA) Write and review Standard Operating Procedures GMP QC compliance in the manufacture of products Record all results carefully following FDA documentation standards Perform environmental monitoring in the lab (checking surfaces / air for contamination) Prepare all paperwork for each test and submit results to Quality Assurance Coordinate with manufacturing staff when samples are ready for testing Usually handle 2–3 full test batches per week Support FDA inspections, internal audits from 3rd parties, and external audits, including completion of customer supplier evaluations and review of supplier agreements Support production and manufacturing activities as needed Assist in training staff on regulatory requirements and internal procedures as applicable Perform additional job-related duties as required. 2+ years of experience in a Quality Control role; prior experience within a cGTP / cGMP regulated biotech, cell processing, tissue bank or pharmaceutical company preferred Demonstrated ability to manage and prioritize multiple projects and meet deadlines Excellent time management and organizational skills Strong written and verbal communication skills Understanding of the fields of aseptic processing, cell therapy and cryopreservation preferred Exceptional analytical skills and solutions-oriented approach to problem-solving Ability to work effectively in a fast-paced, rapidly changing environment Demonstrated ability to work independently as well as part of an integrated team Flexibility and dedication : Position may require some 'off-standard hours'
Job Description
Job Description
QC Technician - Simply Biotech
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.
Immediate opening for a QC Technician in Poway, CA who possess :
- 3-5+ years industry experience with aseptic technique.
- MUST have experience working with endotoxins or mycoplasma
- Must have experience working in an FDA regulated facility, documenting processes and result. (No R&D, please!)
- Bachelor's Degree in a scientific practice or 5+ years industry experience
- Cell therapy experience, a plus!
Email resumes to jgarcia@simplybiotech.com and call 858.683.8070
FULL DESCRIPTION : Quality Control Technician is responsible for working closely with the Quality Control Supervisor to assist in the maintenance of Quality Management Systems. These systems will ensure the safety, efficacy, and purity of the products manufactured. The manufacturing facility is a state-of-the-art, GMP and GTP compliant controlled clean room facility designed to enable production of regenerative medicine products.
The selected candidate will be responsible for :
Develop and maintain the following systems :
Support QA with the day-to-day management of the following
Secondary Responsibilities :
The selected candidate will also possess :
Salary Range : $70k-80k / yr
For immediate and confidential consideration, please email your resume to jgarcia@simplybiotech.com or call 858.683.8070. More information can be found at www.simplybiotech.com
Company Description
Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2022, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, TalentZok is expanding to new markets and hiring additional staff in existing offices.
Company Description
Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2022, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, TalentZok is expanding to new markets and hiring additional staff in existing offices.
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Qc Technician • Poway, CA, US
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