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QA Specialist I

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. This position is also responsible for providing support to the Manufacturing and Packaging operations to ensure relevant procedures are followed and meet cGMP requirements.
Position 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 monitor the resolution.
Assisting as required in the stability department, with validation activities, and/or annual report assembly.
Performs disposition finished product, raw materials, and packaging components. Performs review of finished product stability data.
Perform packaging line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirement.
Performs other duties as assigned or requested.
Position Requirements: - Bachelors degree and 2 years 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 work within a team environment.
Attention to detail
Excellent interpersonal skills.
Excellent Organizational and follow through skills
Excellent written and verbal communication skills.
Knowledge of cGMP's.
Written and verbal communication skills
Must be able to travel occasionally


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