Quality Control - QC Analytical Associate I

Minaris • Allendale, NJ

2d • Hybrid

About The Position

The Quality Control Analytical Associate I 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.

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.
• 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.
• The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
• May work with hazardous materials and chemicals
• Gowning Proficiency as needed.
• The work environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
• This role operates within a professional office environment of a manufacturing operations plant.
• This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.
• Seating is mixed and includes open space seating, cubicle, and office space.
• Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have sufficient vision to read materials.
• Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
• Must have the ability to communicate information and ideas so others will understand.
• Must be able to exchange accurate information in person, and on the telephone.

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.
• May require occasional overtime, weekend, or holiday work to support critical testing deadlines or production schedules.
• Exposure to moderate noise levels and potential biohazardous materials; strict compliance with safety and biosafety procedures is mandatory.
• May be required to participate in periodic extended shifts during critical operations or investigations.

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 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level