Quality Control Sample Management and Operations Associate

Description

• Seeking an energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) team.
• The successful candidate will contribute to the advancement of our product pipeline by playing a crucial role in Quality Control Operations including sample management, equipment management and reagent management in the Quality Control Laboratory.
• This position is essential for ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations.
• This position includes weekend technical support and operates on the following shift and is subject to change.
• The candidate will be primarily responsible for the receipt, storage, inventory, and distribution and preparation of samples, controls, reagents and standards used in analytical testing, utilizing paper and computer-based inventory systems.
• The candidate will also be responsible for the operation, organization and maintenance of Temperature-Controlled Storage Units and ensure that samples, reagents, standards and controls are stored in appropriate temperature conditions utilizing paper and computer-based asset systems.
• The candidate will support the calibration and maintenance activities required for QC equipment using computerized asset management software
• The candidate will complete and document activities in accordance with CGMPs, SOPs, and protocols.
• Perform compendial assays and processing of samples as needed.
• Report deviation events to QC management.
• This position is essential for ensuring that the laboratory meets the high standards required for CGMP lot release and stability testing
• The role also involves contributing to the writing and revision of Standard Operating Procedures (SOPs) and other CGMP documentation.
• The position requires a strong background in laboratory practices, general testing methodology, assay troubleshooting, and familiarity with Quality Systems.
• Ability to follow safety procedures outlined in the Safety, Health and Environmental requirements.
• (Monday to Friday, 5X8, 7am-3:30PM(3 days/per week), 5AM-1:30PM (2 days/per week)
  
  

Qualifications

• Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
• Prefer a Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience.
• Strong experience with receipt, storage, inventory control, and distribution of samples and reagents for analytical testing.
• 1-2 years executing routine and non-routine analysis for CGMP compendial assays (Appearance, pH, etc.)
• Experience in customer service and strong communication skills.
• Familiar with basic computer applications such as Microsoft Outlook, Word and Excel.
• Experience with labeling and preparation of reagents, controls and reference standards.
• Experience operating and maintaining Temperature-Controlled Storage Units, including cryogenic (LN2) freezers.
• The ideal candidate will possess excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.
• Experience in Cell &/or Gene Therapy desired
  
  

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.