Production Laboratory Technician
Location: Richmond, BC, Canada – Head Office
Department: Production and Packaging, Manufacturing
Reporting directly to the Production Manager, this position is responsible for performing a variety of routine small and large-scale bulk reagent processing, manufacturing for use in commercial diagnostic products. Operate a variety of small to large laboratory and reagent mixing equipment and as a back-up to Quality Control.
HOW YOU WILL CONTRIBUTE:
- Handle chemicals and biochemical solutions (HIV/Syphilis) daily.
- Calculate, weigh, measure raw materials to ensure batches manufactured contain correct ingredients and are prepared within established tolerances.
- Prepare routine, simple to moderately complex small and large-scale bulk reagent and buffer formulations, according to established procedures.
- Use and maintain production and laboratory equipment including, but not limited to scales, pH meters, centrifuges, mixing equipment, volumetric devices, spectrophotometer and pipettes.
- Aliquot, dilute and reconstitute chemicals and biochemical solutions (HIV/Syphilis-positive) when required.
- Conduct standard in-process testing to assure production batches meet established specifications.
- Maintain detailed production and experimental records in strict adherence to Quality System and Good Manufacturing Practice (GMP) requirements.
- Assist production lead in defining appropriate scheduling of tasks and optimal inventory levels of raw and work-in-process materials.
- Assist R&D (Research & Development) by providing records and data for experimental and research purposes.
- Responsible for the proper storage and disposal of various hazardous chemicals/biochemical wastes.
- Collaborate with QC (Quality Control) and R&D (Research & Development) in the development and approval of new laboratory equipment/apparatus.
- Perform routine monitoring of both the environmental air and water quality in the laboratory.
- Clean and maintain reagent production glassware and storage containers.
- Perform specified QC (Quality Control) activities as needed.
- Perform incoming verification and inspection activities for raw materials against established quality specifications.
- Perform inspection of INSTI components and finished devices.
- Complete QC (Quality Control) testing records and update associated tracking logs.
- Maintain QC (Quality Control) sample inventory and retention.
- Initiate and complete Out-Of-Specification (OOS), Process Deviations Reports (PDR) and Non-Conformity Reports (NCR) related to Quality Control inspection and Testing.
- Critically analyze test results and participate in investigational testing to support OOS and NCRs.
- Participate in investigations to support Customer Complaint Reports (CCR) and Corrective and Preventive Actions (CAPA).
- Train new Production Laboratory personnel on laboratory activities, procedures and requirements as required.
- Bachelor degree in a life sciences discipline or Diploma in Biotech plus relevant work experience in a medical device manufacturing environment.
- Knowledge of and experience with GLP and GMP.
- Knowledge of or direct experience working in ISO 13485 environment
- Excellent interpersonal skills, oral communication skills, and written communication skills are required
- Ability to read and understand Quality System documentation, standard operating procedures, work instructions, material safety data sheets, technical procedures and maintenance instructions.
- Excellent computer skills (MS Office, Access, Excel)
- Must have availability to meet flexible start and end times including the ability to work or days, afternoons or weekends
- Must be able to work with blood and blood-borne pathogens
WHAT WE OFFER
- A competitive compensation package
- Extended health benefits including dental, optometry, RMT, etc.
- Flexible working hours
- Bonus day off with pay on your Birthday every year
- Complimentary reserved parking
- Complimentary shuttle to/from the office and River Rock Hotel
- Exercise room with a gym and shower facilities
- Opportunity to work with industry experts who are motivated and passionate about what they do but know how to have some fun
HOW TO APPLY
bioLytical Laboratories Inc. offers a challenging, enriching work environment. To apply for this opportunity, please send your cover letter, resume, and salary expectations to firstname.lastname@example.org.
We are an equal opportunity employer and invite applications from all qualified individuals