is a privately held company headquartered in Carlsbad, California just a short distance north of San Diego. Sterogene is a leading provider of downstream processing chromatography resins for the pharmaceutical industry for production of life-saving biopharmaceuticals.
We are seeking an experienced Quality Control Technician. This position reports to the Quality Assurance Supervisor and is primarily responsible for supporting the quality systems department according to cGMP, Federal Regulations, and ISO 9001.
The ideal candidate has excellent documentation and organization skills, pays attention to detail and works independently in a guided environment. He/She is expected to follow established Standard Operating Procedures (SOP) and must be able to handle several projects simultaneously. In this position, she/he will be responsible for the following activities:
Secondary job functions
- Process, test and release raw materials, manufactured intermediate products, and finished products.
- Perform validations of materials, procedures, equipment as directed. Write and submit validation reports
- Perform line clearance and room release for packaging and manufacturing areas.
- Issue, review, process and archive documents as needed/requested to support production and QC functions according to Good Documentation Practice.
- Write and revise Standard Operation Procedures and other controlled documents as directed.
- Perform/assist with employees training on SOPs and other required trainings
- Perform supplier qualification activities as directed
- Perform microbial sampling and testing per current SOPs
- Perform temperature monitoring of refrigerators, freezers, production rooms and other equipment
- Inspect products and documents of packaged products prior to shipment.
- Inspect facility equipment, monitor equipment performance, calibrate as scheduled; take appropriate action for equipment not performing to specifications.
- Develop and implement validation protocols and new QC methods as directed. Work with R&D department and with external laboratories as needed.
- Participate in Internal ISOAudit.
- Assist with preparation for customer and ISO 9001 audits.
- Support manufacturing, packaging and shipping, and other departments as needed/directed.
- Maintain inventory of reagents for QC laboratory, perform and document physical inventory as scheduled.
- Keep an accurate Laboratory Notebook.
· Any other duties as deemed necessary by managementRequirements:
Education and work history:
Bachelor’s Degree in chemistry/ biology or in a related field or equivalent with 2-5 years of experience in QS or in a related area is required. Must be a self-starter with ability to follow, maintain and establish schedules. Knowledge of chromatography techniques, sterile techniques, AKTA, HPLC, GCMS, Infrared Spectroscopy Instrument, Spectrophotometers.
- Must have working knowledge of basic laboratory equipment, sampling and safety procedures.
- Must have basic math skills.
- Ability to write laboratory reports.
- Basic Computer software skills (Microsoft Word, Excel, Power Point).
- Must be able to pay close attention to detail and be pro-active.
- Willingness to work with hazardous materials.
- Must be a self-starter with ability to follow, maintain, and establish schedules.
- Requires attention to small details.
- Ability to multi-task and prioritize work
- Requires sitting for long periods of time; bending and reaching.
- May require working with hazardous materials
- May include working in areas of unpleasant extremes of cold and heat
- May require some manual dexterity and vision sufficient to use laboratory equipment and observation
- May require lifting up to 25+ pounds
Sterogene Bioseparations, Inc. strongly supports equal employment opportunity for all applicants regardless of race, color, religion, sex, gender identity, pregnancy, national origin, ancestry, citizenship, age, marital status, physical disability, mental disability, medical condition, sexual orientation, genetic information, or any other characteristic protected by state or federal law.
Job Type: Full-time
- Dental Insurance
- Health Insurance
- Paid Time Off
- Vision Insurance
- 8 Hour Shift
- Day shift
- Monday to Friday
- Quality: 2 years (Required)
- Carlsbad, CA 92008 (Required)
- Waiting period may apply
- Only full-time employees eligible