Biotechnician I, GMP

Revvity•San Diego, CA

13d•$19 - $23•Onsite

About The Position

At BioLegend, the GMP Biotechnician will work closely with several departments such as QA and inventory control to understand and streamline Manufacturing production processes. This position will be responsible for filling, capping, labeling, completing detailed batch records, putting away finished good inventory (FGI), data entry, equipment maintenance, supply inspections & storage. This role will require verification and sign off on records as well as label creation and inspections. Data entry responsibilities include scanning and attaching records into our system, CoA creation and processing work orders through our Enterprise Resource Planning (ERP) system. Lab duties will entail about 60% of the work and 40% of the work will be administrative tasks. BioLegend’s regulated product produced in our US FDA registered Good Manufacturing Practices (cGMP) manufacturing facility. The duties include vialing of the product according to standard operating procedures. Another part of the job responsibility includes preparing product/project related documentation and maintaining the device history records for all the regulated products.

Requirements

High school diploma/GED or some college.
6 months of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment.
Ability to pipette small volumes.
Ability to perform simple math calculations.
Ability to communicate effectively both orally and in writing
Demonstrated ability to be detail-oriented, organized, work well in small work groups and the ability to adhere to timelines

Nice To Haves

Associate's Degree in Biology, Biochemistry, Chemistry, or other related area.
Working experience in Biotechnology industry with quality system knowledge including ISO 13485 or cGMP regulation is a plus.
Advance pipetting skill is highly preferred.
Familiar with raw material supply receiving and inspection process.
Knowledge of Good Documentation Practices.
Knowledge of aseptic techniques in biosafety cabinet.

Responsibilities

Perform vialing, and labeling of regulated products.
Maintain batch records and other documentations that are essential to be in compliance with ISO13485:2016 and MDSAP regulations.
Maintain laboratory equipment and manage laboratory supplies.
Receiving materials (inspection, organizing/labeling, & updating logs).
Printing labels for final product production.
General buffer formulation.
Washing lab glassware.
Data entry responsibilities.
Other projects or responsibilities as may be required.