Quality Assurance Specialist

Description :

• The Specialist, Quality ensures compliance with quality system's procedures and assessing regulatory and quality risks in activities and processes according to regulatory agency guidelines and company practices.
• This unique role is accountable for routine Quality Assurance responsibilities related to the production and disposition of products manufactured and tested on
• Provide quality assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within to assure compliance to the quality manual and maintain collaborative quality relationships.
• Lead deviations and laboratory investigations related to GMP manufacturing and analytical testing, respectively, with cross-functional owners.
• Determine corrective/preventative actions (CAPA) and Verification of Effectiveness (VoE) and drive on-time implementation and closure.
• Work with appropriate partners to manage change controls in a phase appropriate manner for clinical stage products that supports quality risk management (i.e. New Product Introduction, New Facility, & Manufacturing Process Change Controls).
• Provide ILT trainings for annual GMP/GDP, Quality Manual, Quality Risk Management, Deviation/CAPA, Change Control.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media batch records and in-process/QC/final product labels) to manufacturing.
• Review routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Perform approval of equipment alarm acknowledgements, equipment activation and PM/Calibration schedules in computerized asset and alarm management system(s).
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
• Working Days/Hours: 9am-5pm Sunday- Thursday OR Monday-Friday (possible weekend work)

Qualifications:

• MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required; OR
• BA/BS with 2+ years; OR
• Associate's degree with 4+ years; OR
• High School diploma with 5+ years of Quality Assurance or GMP experience.
• 2-4 years of Cell Therapy Experience
• Knowledge of and ability to apply GMP in conformance to US standards.
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.
• Adapt best practices for stage appropriate products.
• Manufacturing QA experience supporting batch review and product disposition.
• Candidates who have managed deviations from the Quality Assurance perspective, including reviewing deviations through closure and ensuring GMP compliance.
• 2-3 years of directly relevant QA experience who can contribute with minimal training.
• Strong GMP knowledge.
• Must have a QA background and QA operations experience
• Hands-on experience with:
  
  • Batch record review
  • Preparing batches for disposition
  • Deviation management
  • Change controls
  • Batch disposition
  • Deviations (QA reviewer perspective)
  • Good Documentation Practices (GDP)

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/.

LA County Fair Chance Ordinance:

Background Check: In accordance with the LA County Fair Chance Ordinance, we will consider for employment all qualified applicants, including those with a criminal history, in a manner consistent with applicable law. Except as otherwise permissible under applicable laws, you will not be asked to provide information about a conviction history unless you receive a conditional offer of employment. Synectics will make an individualized assessment of whether your conviction history has a direct or adverse relationship with the specific duties of the job, and will also consider potential mitigating factors, including, but not limited to, evidence and extent of rehabilitation, recency of the offense(s), and age at the time of the offense(s). If asked to provide information about a conviction history, any convictions or court records which are exempted by a valid court order do not have to be disclosed.

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 of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.