Quality Assurance Associate

Description:

• Seeking an energetic and experienced individual with cell therapy quality assurance background to join our Quality Assurance (QA) team.
• Will contribute to the advancement of our product pipeline by performing QA batch record review, label review and verifications, document archival of records, and other assigned tasks.
• To independently organize and manage timelines for batch record reviews.
• Reviews routine manufacturing batch documentation and quality control data for in-process and finished product to support disposition and lot closure.
• Review routine material release documentation for quality release of raw materials used for manufacturing and quality control testing.
• Work with Doc Control to ensure archival of batch records.
• Work with QA doc control to ensure accurate issuance of batch record documentation (i.e. lot/media records and labels) to manufacturing.
• 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 with the quality manual and maintain collaborative quality relationships.
• Perform other duties as requested by supervisor/manager to support Quality.
• Administrative Tracking of QA metrics
• On the Floor QA support
• Working Hours: 9am-5pm Sunday- Thursday OR Monday-Friday (possible weekend work)

Qualifications:

• Associate's degree with 1-2 years experience of Quality Assurance or GMP experience; OR
• High School diploma with at least 3 years of Quality Assurance or GMP experience
• BA/BS with 2+ years; OR
• MA/MS in Biology, Chemistry, Microbiology, Engineering, or a related field is required
• PhD candidates are acceptable
• Experience in Cell or Gene Therapy
• Well versed in various cell therapy manufacturing processes
• Batch Record Experience
• Basic GMP/GDP knowledge
• Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
• Flexibility of occasionally working in weekend or holidays to support lot release.
• Demonstrated ability to take ownership, initiative, and self-accountability.
• Demonstrated ability to collaborate, work, and communicate effectively across organizational interfaces in a fast-paced dynamic team setting.
• Attention to detail and quick learning/application of concepts and information.
• Knowledge of cell culture techniques and proficient in MS Word, Excel, Power Point and other applications.
• Ability to communicate and work in a self-guided manner with scientific/technical personnel.
• 1+ year industry experience
• Experience working in a regulated manufacturing environment
• Exposure to: Deviations (supporting or drafting minor ones)
• CAPA
• Strong patient-focused mindset
• Motivated by: Science and cell therapy, Contributing to patient outcomes, Career growth

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 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.