Quality Assurance Specialist

3 weeks ago


Vista, California, United States BIO FILM INC Full time
Job Overview

BioFilm Inc is a leading manufacturer of Astroglide Personal Lubricant and other sexual wellness products, driven by a commitment to excellence and continuous innovation.

We are seeking a skilled Quality Assurance Specialist to join our team, with a strong focus on ensuring the highest industry standards and regulatory requirements for our products.

The ideal candidate will have a Bachelor's degree in Biology, Chemistry, Biotech, or other science-related field, and 1+ years of quality control/quality assurance lab experience, with microbiology experience being a plus.

The successful candidate will be responsible for sampling, inspections, testing, and scheduling for a wide range of samples, including raw materials, in-process items, and finished good products, while following all universal precaution, safety guidelines, and documenting test results.

In this role, you will also perform microbiological, endotoxin, bioburden, and environmental monitoring testing, prepare, maintain, and operate analytical instruments and equipment, order supplies, maintain inventory, and prepare chemical and bacteriological media, reagents, and test solutions used in the laboratory.

You will lead or assist with root cause investigation for OOS, non-conformances, complaints, R&I or production investigations, complete all investigational tasks on-time and in-full, and ensure proper follow-up, closure, and corrective actions based on inspection requirements and status.

This position requires knowledge of CGMP/QSR, GLP, and FDA requirements, with medical device/ISO 13485 experience being preferred. ASQ or Six Sigma Yellow/Green Belt certification is also a plus.

Key Responsibilities:

  • Sampling, inspections, testing, and scheduling for raw materials, in-process items, and finished good products
  • Performing microbiological, endotoxin, bioburden, and environmental monitoring testing
  • Maintaining and operating analytical instruments and equipment
  • Ordering supplies, maintaining inventory, and preparing chemical and bacteriological media, reagents, and test solutions
  • Leading or assisting with root cause investigation and completing investigational tasks
  • Ensuring proper follow-up, closure, and corrective actions based on inspection requirements and status

Requirements:

  • Bachelor's degree in Biology, Chemistry, Biotech, or other science-related field
  • 1+ years of quality control/quality assurance lab experience, with microbiology experience being a plus
  • Knowledge of CGMP/QSR, GLP, and FDA requirements, with medical device/ISO 13485 experience being preferred
  • ASQ or Six Sigma Yellow/Green Belt certification is a plus

Salary: $60,000 - $65,000 per year



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