Werfen North America
Technologist III, QC - San Diego
Werfen North America, San Diego, California, United States, 92189
Position Summary
The QC Technologist III is responsible for the execution of a broad range of bench test procedures used in raw material qualification, testing of finished goods prior to release, investigations of product performance, routine validation studies, and assistance with maintaining the QC laboratory. The role works with cross‑functional teams to resolve product performance issues and maintain QC SOPs in compliance with regulations and ISO standards. This is a temporary role lasting between 3 and 6 months, with a pay rate of $29–$34 per hour depending on experience.
Responsibilities
Perform and organize testing of biological raw materials and finished goods per SOP with minimal supervision; subject matter expertise in at least one product line.
Assist with planning of method, product, and process validations on existing products; perform and organize testing as needed.
Perform testing and prepare reports for environmental monitoring or investigations of out‑of‑specification results.
Perform testing and assist with preparation of reports for special projects as deemed necessary by the technical review team.
Track relevant trends and maintain proper laboratory housekeeping and supply levels.
Document all test results and maintain product release records, including electronic records.
Maintain product testing database and perform relevant statistical analyses associated with product specifications per laboratory SOPs.
Coordinate and assist with investigation and resolution of complaints, non‑conforming material, and product performance issues as required.
Submit complex change orders to update procedures as required.
Work cross‑functionally to investigate and resolve issues deriving from finished product testing.
Ensure and maintain compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes.
Other duties as assigned.
Qualifications
High school diploma required; bachelor’s degree in science or equivalent experience preferred.
Minimum of four years of QC and/or QA experience, preferably in regulated medical device manufacturing or in‑vitro diagnostic device (IVDD) environment.
Thorough understanding of good laboratory practices (GLP).
Practical experience with laboratory controls, internal audits, and lab training/maintenance.
Phlebotomy certification a plus.
Knowledge of FDA‑GMP/QSR and ISO standards for quality.
Excellent written and verbal communication skills.
Ability to work independently and as part of a team.
Proficiency with common laboratory techniques such as pipetting and use of balances.
Proficiency with Microsoft Office suite.
Proficiency with enterprise resource planning (ERP) and laboratory information management systems (LIMS) preferred.
Job Details
Seniority level: Mid‑Senior level
Employment type: Temporary
Job function: Quality Assurance
Industry: Medical equipment manufacturing
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Responsibilities
Perform and organize testing of biological raw materials and finished goods per SOP with minimal supervision; subject matter expertise in at least one product line.
Assist with planning of method, product, and process validations on existing products; perform and organize testing as needed.
Perform testing and prepare reports for environmental monitoring or investigations of out‑of‑specification results.
Perform testing and assist with preparation of reports for special projects as deemed necessary by the technical review team.
Track relevant trends and maintain proper laboratory housekeeping and supply levels.
Document all test results and maintain product release records, including electronic records.
Maintain product testing database and perform relevant statistical analyses associated with product specifications per laboratory SOPs.
Coordinate and assist with investigation and resolution of complaints, non‑conforming material, and product performance issues as required.
Submit complex change orders to update procedures as required.
Work cross‑functionally to investigate and resolve issues deriving from finished product testing.
Ensure and maintain compliance with the company’s quality system requirements through training and adherence to policies, procedures, and processes.
Other duties as assigned.
Qualifications
High school diploma required; bachelor’s degree in science or equivalent experience preferred.
Minimum of four years of QC and/or QA experience, preferably in regulated medical device manufacturing or in‑vitro diagnostic device (IVDD) environment.
Thorough understanding of good laboratory practices (GLP).
Practical experience with laboratory controls, internal audits, and lab training/maintenance.
Phlebotomy certification a plus.
Knowledge of FDA‑GMP/QSR and ISO standards for quality.
Excellent written and verbal communication skills.
Ability to work independently and as part of a team.
Proficiency with common laboratory techniques such as pipetting and use of balances.
Proficiency with Microsoft Office suite.
Proficiency with enterprise resource planning (ERP) and laboratory information management systems (LIMS) preferred.
Job Details
Seniority level: Mid‑Senior level
Employment type: Temporary
Job function: Quality Assurance
Industry: Medical equipment manufacturing
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