QA Associate III

6 months ago

Athens, United States Spectraforce Technologies Inc Full time

Job 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 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.

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.
  • 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.

Education:
Bachelors degree in Life Sciences or Engineering.

  • Research Scientist III

    4 weeks ago

    Athens, Georgia, United States University of Georgia Full time

    Job SummaryWe are seeking a highly skilled Research Professional III to join our team at the University of Georgia. The successful candidate will assist in research procedures in a Biosafety Level 2+ containment environment, perform tissue cultures, immunologic assays, flow cytometry, PCR, DNA cloning in expression vectors, analysis and purification of...

  • Line Leader III, Packaging

    1 week ago

    Athens, United States Boehringer Ingelheim Full time

    Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize...

  • Program Coordinator III

    4 weeks ago

    Athens, Georgia, United States University of Georgia Full time

    About the RoleWe are seeking a highly skilled and motivated Program Coordinator III to join our team at the University of Georgia's Carl Vinson Institute of Government. This role will provide project support and logistics management to our sponsored programs and activities in the fields of Electric Mobility and Energy Infrastructure.Key...

  • Finance Coordinator

    5 months ago

    Athens, United States Georgia Options Inc Full time

    An 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 Quickbooks, balancing checkbooks monthly and providing reports, IIII) Reviewing and reconciling...

  • Technician II/III, Active Ingredient-Fermentation

    4 weeks ago

    Athens, United States Boehringer Ingelheim Full time

    Short Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We...

  • Registered Nurse

    1 week ago

    Athens, United States UT Health Athens Full time

    Join our team as a night shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better. We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education, and financial well-being. We prioritize your well-being with paid...

  • Registered Nurse

    2 weeks ago

    Athens, United States UT Health Athens Full time

    Join our team as an evening shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better. We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education, and financial well-being. We prioritize your well-being with paid...

  • Clinical Nurse III

    4 months ago

    Athens, United States Albany Medical Center Full time

    Department/Unit: Elective Orthopedics - B3W Work Shift: Night (United States of America) B3W Elective Orthopedics: B3West is a 24-bed unit, private rooms in the post-surgical services. The primary population is elective orthopedic surgery & Total Joint surgery. The nursing staff cares for post-surgical patients as well as orthopedic trauma and general...

  • Registered Nurse

    1 week ago

    Athens, United States Ardent Health Services Full time

    Overview Join our team as a night shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better * Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education, and financial well-being. * People-First: We...

  • Clinical Nurse III

    3 months ago

    Athens, United States Albany Medical Center Full time

    Department/Unit:Elective Orthopedics - B3WWork Shift:Night (United States of America)B3W Elective Orthopedics:B3West is a 24-bed unit, private rooms in the post-surgical services. The primary population is elective orthopedic surgery & Total Joint surgery. The nursing staff cares for post-surgical patients as well as orthopedic trauma and general...

  • Registered Nurse

    3 weeks ago

    Athens, United States Ardent Health Services Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Relocation assistance may be available for this position. Join our team as an evening shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Fulfilling your purpose begins here: People First, Always. Here's how we take care of our people: * Medical, vision, dental...

  • Registered Nurse

    1 week ago

    Athens, United States Ardent Health Services Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Join our team as a night shift, full-time, Intermediate Care (IMC) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better * Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your...

  • Registered Nurse

    3 weeks ago

    Athens, United States UT Health Athens Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Relocation assistance may be available for this position. Join our team as an evening shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Fulf illing your purpose begins here: People First, Always . Here’s how we take care of our people: Medical, vision, dental health...

  • Registered Nurse

    2 weeks ago

    Athens, United States UT Health Athens Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Join our team as a day shift, full-time, Medical Surgical Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness, education,...

  • Registered Nurse

    2 weeks ago

    Athens, United States UT Health Athens Full time

    Overview You may be eligible for a sign-on bonus up to $20,000. Join our team as a night shift, full-time, Labor & Delivery (L&D) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better Thrive: We empower our team with career growth opportunities, tuition assistance, and resources that support your wellness,...

  • Registered Nurse

    2 weeks ago

    Athens, United States UT Health Athens Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Relocation assistance may be available for this position. Join our team as an evening shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better Thrive: We empower our team with career growth opportunities,...

  • Registered Nurse

    3 weeks ago

    Athens, United States Ardent Health Services Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Join our team as a day shift, full-time, Medical Surgical Registered Nurse (RN) in Athens, TX. Fulfilling your purpose begins here: People First, Always. Here's how we take care of our people: * Medical, vision, dental health insurance, health savings account / flexible spending,...

  • Registered Nurse

    3 days ago

    Athens, United States Ardent Health Services Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Relocation assistance may be available for this position. Join our team as an evening shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Why Join Us? Thrive in a People-First Environment and Make Healthcare Better * Thrive: We empower our team with career growth...

  • Registered Nurse

    3 weeks ago

    Athens, United States UT Health Athens Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Relocation assistance may be available for this position. Join our team as an evening shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Fulf illing your purpose begins here: People First, Always . Here’s how we take care of our people: Medical, vision, dental health...

  • Registered Nurse

    3 days ago

    Athens, United States Ardent Health Services Full time

    Overview You may be eligible for a sign-on bonus of up to $20,000. Relocation assistance may be available for this position. Join our team as a night shift, full-time, Emergency Room (ER) Registered Nurse (RN) in Athens, TX. Thrive in a People-First Environment and Make Healthcare Better * Thrive: We empower our team with career growth opportunities,...