New Quality Associate Job in Hayward, CA!
Position Title: Quality Associate

Position Number: 339312

Location: Hayward, CA 94541

Position Type: Temporary

Required Skill Set:

GMP, Pharmaceutical, Quality Analyst, Quality Assurance, SOP

Position Description:

**C2C is not available**
**Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.**
Job Title: Quality Associate
Start Date: 05/04/2020
End date: 11/01/2020
Location: Hayward, CA 94541

(Main purpose of the job) The incumbent will work with Sterilization and Sterility Assurance activities including sterilization cycle validations, re-qualifications, Environmental Monitoring activities and Change control activities for the areas under responsibility.
Essential Duties and Responsibilities
(List of primary responsibilities of this role that account for 5% or more of the work. Incumbent may perform other duties as assigned.) • 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.
(To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.) • 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
Education and/or Experience • 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.

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Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.)
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