QA Specialist

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 the 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. Reviews finished product stability data.
• Performs packaging line inspection/audits and provides assurance that packaging operations are compliant with applicable SOPs and cGMPs.
• Conducts finished product attribute sample inspection and evaluates finished products physical characteristics prior to packaging.
• Conducts 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 CFR
  21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
• Performs other duties as assigned or requested.

• Bachelor’s degree and 2 years experience working within Quality Assurance or Quality Control.
• Good understanding of laboratory testing and raw data, particularly HPLC.
• Previous work in a regulated environment.
• 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.
• Excellent interpersonal skills.
• Excellent organizational and follow-through skills.
• Excellent written and verbal communication skills.
• Knowledge of cGMPs.
• Must be able to travel occasionally.

The base salary range for this position is $48,000 - $52,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition, ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.