Quality Technician

Job Information

• Work Experience: Minimum 1 year of experience
• Salary: $20 to $24/hour
• City: Modesto
• State/Province: CA
• Country: United States
• Zip/Postal Code:95350

Job Description

The Quality Assurance Technician position is responsible for daily quality checks, environmental monitoring, completing documentation, training verifications, competency evaluations, in-process controls, verification of outgoing products, and supporting the company’s Quality Policy. This position will require the employee to work in a team environment to resolve applicable issues as they arise. 

DUTIES AND RESPONSIBILITIES:

• Must be a team player as measured by his/her peers.
• Assist department and site with enforcement of SPSA’s Quality Policy and Quality Management System, maintaining compliance with ISO 13485:2016, FDA 21 CFR Part 820, and AAMI ST79:201.
• Ensure quality functions are performed according to SPSA’s written Standard Operating Procedures, written Work Instructions, and cGMP at each site.
• Assist with training of employees, annual updates and other required instruction as needed. (Training programs include but are not limited to, new hire, blood borne pathogens, annual retraining, retraining of content tied to client complaints, and new/revised documents.)
• Audit all documents to ensure they are completed according to cGMPs, and GDPs.
• Complete all quality logs as required, according to written work instructions.
• Audit job performances to ensure SPSA procedural compliance.
• Assist with testing such as—bioburden, airborne environmental sampling, load biological indicator (BI) reading, or other testing, calibration studies, re-qualification studies, etc., as required.
• Perform various inspections, such as intake, in-process, and post-process release inspections to assess and ensure quality of finished goods.
• Assist with the complaint documentation program by conducting investigations of product or service complaints as directed by Quality Assurance leadership.
• Support site or team with RCA (Root Cause Analysis) assessments, as needed.
• Identify and report any non-conformances or deviations.
• Maintain proper documents, files, and required records.
• Support tracking of quality findings and assist with trend analysis, as required.
• Daily functions could include, but are not limited to:
  • Walk throughs around the facility during each shift to ensure ongoing compliance.
  • Final disposition, release and sign-off of individual sterile loads by performing inspections.
  • Prepare BI read/report, and Certificate of Conformance (CofC).
  • Assist in maintaining sterility batch records.
  • Perform incoming inspections of raw materials.
  • Assist in reconciling or auditing customer travel documents.
  • Recommend any necessary adjustments and changes to processes for continuous improvement.
  • Place equipment on QA hold as deemed necessary.
  • Release equipment with the approval of QA Leadership.
  • Perform random or heightened inspections.

SUPERVISORY RESPONSIBILITIES:

None

WORKING CONDITIONS:

Work is performed in a fast-paced indoor production area with little exposure to dust and high temperatures; moderate exposure to excessive noise; climate-controlled environment; and controlled access. Possible exposure to bio-hazardous materials and strong odorous chemicals or elements.

Qualification Requirements

EXPERIENCE:

Minimum 1 year of quality assurance or quality control experience. Medical device experience preferred.

EDUCATION:

High school diploma or GED required. Two-year degree preferred.

KNOWLEDGE, SKILLS, ABILITIES:

• Must read, write, and understand the English language.
• Must be extremely detailed-oriented and well organized with the ability to maintain precise records.
• Verbal ability to assertively interact with all levels of personnel from junior associates to senior management on all Quality matters.
• Ability to manage time effectively and work with minimal supervision.
• Working knowledge of computer programs, such as Word and Excel.
• Excellent written communication skills.
• Flexible with work hours; Saturday work will be required on occasion.
• Ability to communicate effectively with supervisors and coworkers.
• Ability to read and understand applicable written instructions to include Standard Operating Procedures.

SPSA IS AN EQUAL EMPLOYMENT OPPORTUNITY EMPLOYER
SPSA offers competitive compensation and comprehensive benefits.

Resumes should be submitted to careers@spsausa.com