QA Associate III

• Location: Gainesville, GA
• Type: Contract
• Job #38110

Duties: Responsible for executing and supporting QA operation functions including assess, evaluate, and review operations on the floor against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation. Perform QA inspections of finished goods and other materials. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be proactively shared across QA and the business. Identifies, classifies and reports deviations, as appropriate. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timelyclosure of investigations. Provides guidance directives regarding remediation activities required to continue production. Oversees execution of remediation/CAPA activities required to continue production or move a process along. Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities as well as logging and filing of documentation. Ensures all specifications are met and that requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and approved and are compliant with cGMPsand SOPs and current manufacturing regulations and site procedures.

This is the pay range that Magnit reasonably expects to pay for this position: $30.22 – $32.36

Skills: Capability to establish good relationships with others who have different values, cultural styles and perspectives. Setting high and ambitious goals and standards for oneself and others, continuously raises the bar. Three (3) to five (5) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas. Strong independent judgment and decision making abilities required. Knowledge of relevant regulatory guidances. Demonstrated problem-detection and problem-resolution skills required. Strong conflict resolution and negotiation skills required. Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple tasks. Must possess excellent verbal and written communication skills; good interpersonal skills.

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Education: Bachelors degree in Life Sciences or other applicable field