- Responsible for executing QA operations and overseeing junior team members as they 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 must be proactively shared across QA and the business including the on-going training of junior team members.
- 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. 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. Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue. Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.
- This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader 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 to appropriate departments.
- Works closely with others to recognize opportunities for improvement and drive change through the use of client's Quality Systems.
- 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.
- 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 Strong 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 projects. Must possess excellent verbal and written communication skills; good interpersonal skills.
-
QA Associate III
Found in: Lensa US 4 C2 - 2 days ago
Spectraforce Technologies Athens, United StatesJob Title: QA Associate III · Location: Athens, GA 30601 · Duration: 06 Months · Details: · Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real ...
-
QA Associate III
Found in: Lensa US 4 C2 - 3 days ago
System One Athens, United StatesJob Title: QA Associate III · Location: Athens, GA · Type: Contract, Potential for extension or conversion to permanent · Responsibilities · + Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor ( ...
-
QA Associate III
Found in: Lensa US 4 C2 - 1 day ago
System One Holdings, LLC Athens, United StatesJob Title: QA Associate IIILocation: Athens, GA Type: Contract, Potential for extension or conversion to permanentResponsibilities Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined a ...
-
QA Associate III
Found in: Lensa US 4 C2 - 3 days ago
eTeam Athens, United StatesTitle: QA associateLocation: Athens, GADuration: 6 monthsJob Responsbilities: Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against cGMPs to assure real time observation o ...
-
QA Associate III
Found in: Lensa US 4 C2 - 3 days ago
The Fountain Group Athens, United StatesHello,My name is Arnold, and I am a Senior Talent Acquisition Consultant with The Fountain Group. We are a national staffing firm with an array of Fortune 500 clients constantly looking for candidates such as yourself to join the team. I believe you have a great background and wo ...
-
QA Associate III
Found in: Lensa US 4 C2 - 5 days ago
LanceSoft Athens, United StatesDuties: Responsible for executing QA operations and overseeing junior team members as they 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 ti ...
-
Finance Coordinator
Found in: Lensa US 4 C2 - 1 day ago
Georgia Options Inc Athens, United StatesAn Overview: · Performgeneral accounting functions and processes for the organization and the peopleit supports. · Some duties include: · I) Paying bills and writing spending checks, · II) Ensuring benefits are deposited, · III) Inputting all financial transaction in Quickbo ...
-
Research Professional III-Karen Norris
Found in: One Red Cent US C2 - 1 day ago
University of Georgia Athens, United StatesPosting Details · Posting Details · Posting Number · S09981P · Working Title · Research Professional III-Karen Norris · Department · VetMed-Vaccines & Immun Ctr · About the University of Georgia · Since our founding in 1785, the University of Georgia has operated as Georgia's old ...
-
Assistant or Associate Professor
Found in: One Red Cent US C2 - 23 hours ago
University of Georgia Athens, United StatesPosting Details · Posting Details · Posting Number · F1663P · Working Title · Assistant or Associate Professor - Molecular Plant Virology · Department · CAES-Plant Pathology · About the University of Georgia · Since our founding in 1785, the University of Georgia has operated as ...
-
Systems and Discovery Librarian
Found in: Talent US A C2 - 1 day ago
InsideHigherEd Athens, United States Administrative Jobs ,Posting Number:F1948P · Working Title:Systems and Discovery Librarian · Department:Libraries-Digital Library · About the University of Georgia:Since our founding in 1785, the University of Georgia has operated as Georgia's oldest, most comprehensive, and most diversified institut ...
-
Maintenance Mechanic
Found in: beBee S2 US - 2 weeks ago
Waste Management High Shoals, United StatesAs an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or veteran status. · Tired of just doing preventative mai ...
-
Heavy equipment Technician
Found in: beBee S2 US - 2 weeks ago
Waste Management High Shoals, United StatesAs an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, or veteran status. · Tired of just doing preventative mai ...
QA Associate III - Athens, GA, United States - Spectraforce Technologies Inc
Description
Job Title: QA Associate III
Location: Athens, GA 30601
Duration: 06 Months
Skills:
Education:
Bachelors degree in Life Sciences or Engineering.