Associate, Quality Control Analytical

Synectics Inc.; Los Angeles (CA); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Synectics Inc. in California seeks a QC Operations specialist to advance our CGMP program through sample management, equipment and reagent handling in the QC Laboratory.

You will ensure CGMP compliance and help with SOPs and deviation reporting, with an emphasis on accurate documentation and temperature-controlled storage. Responsibilities include receiving, storing, inventory, and distribution of samples and reagents, supporting calibration of QC equipment, and contributing to CGMP lot release

Formación

• CGMP lab experience and good documentation practices.
• Receipt, storage, inventory control, and distribution of samples and reagents for analytical testing.
• 1–2 years executing routine and non-routine CGMP compendial analyses (Appearance, pH, etc.).
• Customer service experience and strong communication skills.

Responsabilidades

• Support temperature-controlled storage and manage cryogenic LN2 freezers.
• Help calibrate and maintain QC equipment using asset management systems.
• Document activities per CGMPs, SOPs, and protocols.
• Write and revise CGMP documentation and SOPs.
• Report deviation events to QC management.

Conocimientos

QC Lab

Document Control

Inventory Management

Assay Execution

Customer Service

MS Office

Reagent Labeling

Temperature-Controlled Storage

Cryogenic Freezers

Data Analysis

Cell/Gene Therapy

QC Operations

Educación

Associate's degree in Biology

Bachelor's degree in Biology

Descripción del empleo

Description

• 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.
• Ensuring that the laboratory meets the high standards required for CGMP Quality Control Operations.
• 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.
• 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.
• Support the calibration and maintenance activities required for QC equipment using computerised asset management software
• 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.
• Perform other duties as assigned.
• Ability to follow safety procedures outlined in the Safety, Health and Environmental requirements.
• Routine lifting of cryogenic racks weighing up to 25 pounds.

Qualifications

• Associate's degree preferably in Biology or equivalent with 2-3 years of relevant CGMP laboratory experience
• Bachelor's degree preferably in Biology or equivalent with 1-2 years of relevant CGMP laboratory experience.
• Strong experience with good documentation practices, 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.
• Excellent attention to detail, strong communication skills, and the ability to analyze raw data effectively.
• Experience in Cell &/or Gene Therapy
• Energetic and experienced individual with cell therapy quality control background to join our Quality Control (QC) Operations team.
• Schedule: Friday - Monday; 12:00PM to 10:00pm (4/10 schedule)

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

Synectics is an equal opportunity employer.