QA Specialist

Responsibilities

• Assure quality of documentation and data; perform disposition of batch records for raw materials, packaging components, finished product release, and stability documents.
• Support Manufacturing and Packaging operations to ensure procedures are followed and meet cGMP requirements.
• Review notebooks, data sheets, electronic/ancillary data, logbooks, and reports for compliance with corporate SOPs and FDA guidelines; identify GMP deficiencies, initiate documentation for corrective actions, and monitor resolution.
• Assist in stability department with validation activities and/or annual report assembly.
• Perform disposition of finished product, raw materials, and packaging components; review finished product stability data.
• Conduct packaging line inspections/audits; verify packaging operations comply with applicable SOPs and cGMPs.
• Perform finished product attribute sample inspections and evaluate physical characteristics prior to packaging.
• Conduct annual retain sample inspections and manage finished product and raw material retain samples in the reserve sample room.
• Monitor GMP areas for compliance with general GMP requirements (e.g., proper gowning and cleanliness).
• Perform other duties as assigned.

• Bachelor’s degree and 2 years’ experience in Quality Assurance or Quality Control.
• Knowledge of laboratory testing and raw data, particularly HPLC.
• Excellent computer skills; prior experience in a regulated environment.
• Problem solving skills; ability to coordinate multiple tasks in a fast‑paced environment.
• Ability to read and follow procedures; work independently and in a team.
• Attention to detail; excellent interpersonal and organizational/follow‑through skills.
• Excellent written and verbal communication skills.
• Knowledge of cGMPs.
• Must be able to travel occasionally.

• Base salary range: $48,000–$52,000.
• Benefits include health/life/disability insurance, retirement savings plans, paid leave, paid holidays, and paid time off (many subsidized or fully paid).