QA Specialist I

About the role

This position will assure the quality of documentation and data, and assigned disposition of batch records for raw materials, packaging components, finished product release and stability documents. The role supports Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.

Responsibilities

• Reviews data, including notebooks, data sheets, electronic data, ancillary data, logbooks, etc., as well as reports of results for compliance with corporate SOPs and FDA guidelines.
• Highlights GMP deficiencies, initiates the required documentation process, facilitates the implementation of corrective actions and monitors resolution.
• Assists as required in the stability department, with validation activities, and/or annual report assembly.
• Performs disposition of finished product, raw materials, and packaging components.
• Performs review of finished product stability data.
• Performs packaging line inspection/audits and provides assurance that packaging operations are compliant with applicable SOPs and cGMPs.
• Performs finished product attribute sample inspection and evaluation of finished products’ physical characteristics prior to packaging.
• Performs annual retain sample inspections and controls finished product and raw material retain samples stored in the reserve sample room.
• Monitors GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per 21 CFR Subpart A General Provisions, to ensure they reflect current practices and meet industry standards and cGMP requirements.
• Performs other duties as assigned or requested.

Qualifications

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

Pay

The base salary range for this position is $54,000 – $78,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge.

Benefits

• Health insurance coverage
• Life and disability insurance
• Retirement savings plans
• Paid leave programs
• Paid holidays and paid time off