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.