Chemistry Mfg Technician

Job Title:
Chemistry MFG Technician I

Location:

San Diego, CA
Pay: 22.85/hr

Description:

• 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. Bio Legend 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.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Perform vialing, and labeling of regulated products.
• Maintain batch records and other documentations that are essential to be in compliance with ISO
  13485:2016 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 may be required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Perform vialing, and labeling of regulated products.
• Maintain batch records and other documentations that are essential to be in compliance with ISO
  13485:2016 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 may be required.

• Associate's Degree in Biology, Biochemistry, Chemistry, or other related area.

• 0-6 months of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment.

• Demonstrated ability to be detail-oriented, organized, work well in small work groups and the ability to adhere to timelines.
• Knowledge of Good Documentation Practices.
• Knowledge of aseptic techniques in biosafety cabinet.
• Ability to pipette small volumes.
• Ability to perform simple math calculations.
• Ability to communicate effectively both orally and in writing

Preferred Qualifications Education and Experience

• 2 years of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment.

• 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.