QA Associate in Gainesville, GA
- Title: QA Associate
- Code: RCI-18172821
- RequirementID: 105291
- Location: Gainesville, GA 30501
- Posted Date: 01/24/2023
- Duration: 4 Months
- Name:Manshi Negi
- Email: Manshi.Negi@rangam.com
- Phone: 908-704-8843 ✖ 244
- 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 timely closure 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 cGMPs and SOPs and current manufacturing regulations and site procedures.
- 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.
- Bachelors degree in Life Sciences or other applicable field
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