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Quality Assurance Specialist I

2 months ago

Hayward, California, United States Adecco USA Full time

Adecco is seeking a detail-oriented and skilled Quality Assurance Specialist I to become part of our client's team. This position is centered on assisting the batch release department by evaluating and approving batch production documentation while providing quality assurance support to manufacturing teams.

Key Responsibilities:

  • Conduct timely quality assurance evaluations and approvals of in-process and finished goods documentation, ensuring adherence to standard operating procedures (SOPs) and regulatory requirements.
  • Develop, revise, and assess standard operating procedures (SOPs).
  • Engage in on-site quality assurance activities, including inspections and verifications.
  • Guarantee the quality and consistency of documentation, in compliance with SOPs.
  • Maintain proficiency in quality systems and oversee change control requests.
  • Support initiatives for continuous improvement and related projects.
  • Participate in both internal and external audits, addressing any findings.
  • Ensure that training requirements are fulfilled and documented.
  • Monitor and report on departmental performance metrics.
  • Work closely with the Manufacturing department to provide ongoing quality support.
  • Represent the Quality Assurance team in cross-functional meetings, contributing insights and decision-making.
  • Deliver training to various teams and departments as necessary.
  • Assist the department supervisor/manager with scheduling and workload distribution.
  • Identify and promote improvement opportunities utilizing lean manufacturing and six sigma methodologies.

Qualifications:

  • Highly detail-oriented with a strong dedication to quality.
  • Knowledgeable in current Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
  • Familiarity with FDA regulations (Part 820, 211), ISO 13485, and other pertinent regulations.
  • Proven capability to train others, drive results, and meet deadlines.
  • Proficient in Microsoft Office applications (e.g., Word, Excel).
  • Demonstrated attention to detail and accuracy.
  • A general understanding of quarantine and warehouse operations is advantageous.
  • Flexibility to work varying hours as required.

Education and Experience:

  • Bachelor's degree in a related field or equivalent experience.
  • Experience with medical device (21CFR820, ISO 13485, CMDR, MDD) and/or biologics regulations is preferred.

Physical Requirements & Work Environment:

  • Consistent attendance is essential.
  • Ability to perform light lifting up to 40 lbs. and frequent standing/walking.
  • Standard office environment with computer, phone, files, fax, and copier use.
  • Personal Protective Equipment required: Latex-Free Gloves, safety shoes, and safety goggles.

Pay Details: $33.00 per hour

Benefit offerings: Our associates enjoy a range of benefits including medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. Additionally, associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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