Quality Control - QC Analytical Associate I
About The Position
The Quality Control Analytical Associate serves as a support role in clinical and commercial production. The QC Analytical Associate I will assist with process check point, stability, and release analytical testing to ensure that quality standards are upheld for all products produced at the facility. Essential Functions and Responsibilities Under the direction of the QC supervisor or manager, responsibilities of the QC Analytical Associate I will include but are not limited to: Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations Performs maintenance, monitoring, and troubleshooting of pertinent equipment Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP guidelines Participates in supporting in managing QC materials and supplies Support and assistance in equipment and method qualification/validation activities as needed Performs reagent and media preparation as per client or general procedures Provides input and support based on level of knowledge and experience with troubleshooting malfunctioning equipment Perform cleanings of laboratory equipment (incubators, refrigerators, freezers, etc.,) per SOP. Performs equipment and method qualification/validation activities as needed Support investigating out-of-specification, out-of-trend, aberrant, and/or non-conforming test results Support Initiation of deviations with input from QC management Assist in managing client specific QC data and documentation on shared drive or client SharePoint sites Support Support brainstorming and implementation of corrective and preventive actions, as and when applicable Complete all documentation according to the written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
Requirements
- Proficient in computer software including Microsoft Office (Word, Excel, PowerPoint) and Visio for documentation and process mapping.
- Communicates effectively with co-workers, cross-functional teams, management, and clients, both verbally and in writing.
- Strong written and oral communication skills, able to prepare clear and concise reports and documentation.
- Detail-oriented with the ability to multitask efficiently in a fast-paced, team-oriented environment.
- Flexible and adaptable to changing priorities, company growth, and evolving job responsibilities.
- Bachelor’s degree in scientific discipline or a relevant field is required.
- Comply with all applicable FDA, EU, and global regulatory requirements and cGMP standards relevant to QC laboratory operations.
- Follow established SOPs, protocols, and quality system procedures rigorously to ensure accuracy and reliability of test results.
- Maintain strict data integrity by documenting all laboratory activities accurately, completely, and in a timely manner.
- Participate actively in training programs to stay current with quality standards and best practices.
- Support audit readiness by ensuring proper documentation and laboratory cleanliness as required.
- Report any deviations, non-conformances, or quality concerns promptly to supervisors.
Nice To Haves
- Prior experience or certification in cGMP from an accredited program is preferred.
- Previous academic and/or industrial experience in cell and gene therapy is highly desirable.
- Familiarity with QC assays such as complete blood count (CBC), cell count and viability, and basic knowledge of flow cytometry is an advantage.
- A minimum of 6 months to 2 years of experience in a Quality Control laboratory or within the biopharmaceutical industry is preferred.
Responsibilities
- Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations
- Performs maintenance, monitoring, and troubleshooting of pertinent equipment
- Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP guidelines
- Participates in supporting in managing QC materials and supplies
- Support and assistance in equipment and method qualification/validation activities as needed
- Performs reagent and media preparation as per client or general procedures
- Provides input and support based on level of knowledge and experience with troubleshooting malfunctioning equipment
- Perform cleanings of laboratory equipment (incubators, refrigerators, freezers, etc.,) per SOP.
- Performs equipment and method qualification/validation activities as needed
- Support investigating out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
- Support Initiation of deviations with input from QC management
- Assist in managing client specific QC data and documentation on shared drive or client SharePoint sites
- Support Support brainstorming and implementation of corrective and preventive actions, as and when applicable
- Complete all documentation according to the written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
