Quality Control Associate- Bio/Med Device

6 days ago

Carlsbad, United States Ultimate Staffing Full time
Position Overview

Ultimate Staffing Services is seeking a dedicated and detail-oriented Quality Control Associate to join a dynamic team in California. The ideal candidate will play a crucial role in maintaining the quality standards of the company's products and processes. This role is vital for ensuring that all operations comply with the applicable guidelines and regulations.

Responsibilities

  • Execute incoming inspection of raw materials in accordance with company policy and procedures.
  • Conduct environmental monitoring for the facility on a routine basis per applicable SOPs, including sampling of the USP Purified Water system and associated plant utilities.
  • Assist in the expedition of test sample shipment to sponsors and third-party laboratories.
  • Execute deviation/OOS investigations and implement CAPAs and change controls per GMP requirements, as needed.
  • Assist in the execution of analytical method transfer activities, including product-specific test methods.
  • Directly contribute to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines.
  • Analyze on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications.
  • Assume the role of safety liaison with EHS and Safety Officer.
  • Assist QA in calibration/preventive maintenance activities associated with lab instrumentation.

Qualifications

  • Undergraduate degree (B.A. or B.S.) in a Life Science discipline.
  • 3-4 years' GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields.
  • Direct experience with EM sampling and aseptic technique.
  • The ability to perform daily tasks with a keen attention to detail.
  • An affinity for precise and detailed documentation skills.
  • The ability to work effectively and contribute to a dynamic and fast-paced work environment.
  • Well-developed oral communication and listening skills.
  • Applicable academic or industrial laboratory experience.
  • High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction.

Required Work Hours

Monday - Friday, 1st shift

Benefits

  • Medical, Dental, and Vision Insurance
  • Company-Paid Life Insurance
  • Voluntary Life Insurance Options
  • Long-Term and Short-Term Disability
  • Flexible Spending Account (FSA) and Health Savings Account (HSA)
  • 401(K)
  • 14 days of PTO
  • 10 paid holidays

Additional Details

Salary range: $36 - $42 per hour

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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