Specialist I, Quality Assurance

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Responsibilities

Quality System Support:

• Assist in managing quality systems such as deviations, change controls, CAPAs, and document control.
• Support thorough and timely investigations of deviations and assist in documenting root cause analyses and corrective actions.
• Help review and document change controls in compliance with regulatory requirements and internal procedures.
Batch Disposition Support:
• Support the review of batch records and related documentation, assisting in the evaluation of batch release data.
• Collaborate with manufacturing and quality control teams to document and address any quality issues during batch processing.
Document Management & Regulatory Support:
• Assist in maintaining the document management system, ensuring accuracy and compliance with regulatory standards.
• Help prepare quality documentation for internal and external audits and support adherence to cGMP protocols.

Training, Collaboration, and Continuous Improvement :

• Provide basic training and support to staff on quality systems and procedures.
• Collaborate with cross-functional teams, including manufacturing and research & development, to assist in quality improvement initiatives.
• Participate in continuous improvement efforts and track the progress of quality-related activities.

General Requirements

• Bachelor’s degree in a relevant scientific discipline (e.g., biology, biochemistry, immunology) with 1–3 years of related experience in quality control testing, analytical development, or GMP environments.
• Basic understanding of FDA regulations, GMP compliance, and quality system processes.
• Exposure to internal audit processes and document control is a plus.
• Strong organizational skills, attention to detail, and a commitment to data integrity.
• Excellent communication skills and the ability to work both independently and as part of a team in a fast-paced, regulated environment.
• Willingness to learn, adapt, and work overtime as necessary, while consistently adhering to cGMP policies and procedures, including proper documentation and use of personal protective equipment.