Quality Associate II

  • location: Hayward, CA
  • type: Contract
  • salary: $28 - $32.63 per hour
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job description

Quality Associate II

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!

 
location: Hayward, California
job type: Contract
salary: $28.00 - 32.63 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Perform Validation and requalification of Sterilization cycles.
  • Support Environmental Monitoring activities such as EMPQ updates, room validations, etc.
  • Initiate and own change controls activities related to Sterilization, Sterility Assurance or Environmental Monitoring Activities.
  • Assist in implementing quality & regulatory requirements (e.g., FDA, GLP, cGMP, USP, DP, JP, & CFR rules/guidelines).
  • Ensure compliance with SOPs & specifications.
  • Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality & provide new product support.
  • Maintain expenses at or below budget for the lab.
  • Prepare, review and revise, as required, SOPs and specifications.
  • Write memos, reports, protocols, CPAs & other appropriate documentation as required.
  • Identify continuous improvements opportunities
  • Proactive planning and coordination of projects are essential to maintain and continuously improve the quality, cost, and delivery of the products.
  • May perform other duties as assigned.
 
qualifications:
  • Bachelor's degree in science preferable in Microbiology.
  • Minimum of 3- 5 years of experience in Quality, or related field in the medical device/Pharma industry.
  • Experienced in Sterilization, Sterility Assurance and Environmental Monitoring activities preferable.
  • Knowledge of FDA/ISO Regulations, Application of Good Documentation Practices, and Application of Good Manufacturing Practices
  • Must be a strong team player with good problem solving, and good verbal and written communication skills.
  • Must be able to handle multiple projects concurrently and work effectively and efficiently with a cross-functional team
  • Ability to develop and present a course of action with minimal assistance
  • Ability to prioritize multiple tasks and work in a fast-paced environment with accountability for deadlines
  • Knowledge of statistical analysis tools
 
skills: GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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