We have a contract opportunity for a Senior cGMP QA Specialist in Athens Georgia. This position is initially approved for 5 months and could be extended.
Pay Rate: $30.00/Hr.
Job Description: Responsible for executing QA operations and assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information proactively shared across QA and the business. Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations. Works closely with others to determine root cause and potential preventative/corrective actions. Provides guidance directives regarding remediation activities required to continue production. Oversees execution of remediation/CAPA activities required to continue production. Resolve critical issues within area assigned and may escalate to senior management. Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. Providing plan creation oversight, verifying changes adhere to local SOPs and regulatory compliance ensuring communication/escalation of issues with broad impact to the business. Performs independent technical review of documentation including Batch Production Records during and post-execution of cGMP activities. Has authority to sign off/qualify/train junior staff on QA Operation responsibilities. 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 prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings. Works closely with others to recognize opportunities for improvement and drive change through the use of BIFI' Quality Systems. Skills: Capability to establish good relationships with others who have different values, cultural styles and perspectives. Setting ambitious goals and standards for oneself and others, continuously raises the bar. Five (5) to seven (7) 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. Project management experience and strong knowledge of relevant regulatory guidances. Demonstrated problem-detection and problem-resolution skills required. Education:
Bachelors Degree in Life Sciences or Engineering
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
