Quality Control Technician

1 week ago

Irvine, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • The Quality Control Analyst is responsible for conducting the cell-based potency assays(CBPA) of biologics for release and stability of both commercial and late-stage biologics under current good manufacture practice(cGMP).

  • Prepare all documentation associated with the cGMP testing and independently or in a team setting execute protocols in support of manufacture of biologics product.

  • The position is responsible for cGMP compliance of the quality control CBPA laboratory, ensuring that all cell Based Potency Assays testing is performed according to the FDA, foreign MOH and requirements.

  • Perform cGMP testing in support of the manufacture of biologics products.

  • Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.

  • Review and approve raw data and laboratory logbooks/worksheets.

  • Perform cell culture and cell banking.

  • Manage critical reagents and supplies.

  • Write quality systems records including laboratory investigations, change controls, non-conformances.

  • Support regulatory inspections where needed.

  • Perform and execute activities supporting CBPA lab such as equipment validation, equipment preventive maintenance.

  • Generate and update SOPs.

  • Regulated Responsibilities (including cGMP and EHS):

  • Be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

  • Will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications:

  • MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience; OR

  • BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.

  • Proficiency in TrackWise, Microsoft Project, and Excel.

  • Experience in a GMP regulated environment.

  • Experience in bioassays, Chemi-ELISA preferred.

  • Experience with aseptic cell culture and cell banking preferred.

  • Experience with the application of aseptic cell culture and 96-Well format bioassay techniques for potency determination of proteins and their degradation and modification products

    California Fair Chance Act:

    Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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