PRIMARY DUTIES AND RESPONSIBILITIES:

1. Adheres to all cGMP, safety regulations, and understands QA SOP's with minimal
Supervision.
2. Will assist the Center Quality Leaders with all quality operations and responsibilities at the facility.
3. Ensure compliance to procedures and address non-compliance issues.
4. Complete on the floor quality audits during the manufacturing processes; knowledge of AQLs and visual inspection preferred
5. Good understanding of batch record execution, GMP and GDP
6. Work effectively with operators on the floor and make on the spot, risk based decisions; escalate issues to management as necessary
7. Assist in developing and delivering robust overall quality systems resulting in a fully compliant operations
8. On the floor Batch record review: Ability to review controlled documentation during processing for GMP and GDP
9. Non-conformance/CAPA Management support and initial review of Non-conformances and CAPAs:
10. Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans and assist in determining a root cause
11. In process sampling/ AQL sampling : Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, and finished product
12. Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the production process.
13. Provide Quality oversight to Quality Control function.
14. Will perform review of quality related documents generated at the facility.
15. Other duties and responsibilities as assigned.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

1. Minimum 1+ years experience in Quality, Operations, or related field in the healthcare industry. BS in science or related field is desired.
2. Basic PC skills including MS Word and Excel.
3. Demonstrated understanding of quality assurance in a regulated environment.
4. Effective problem solving, strong communication (written and verbal) and organizational skills.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

1. Working in an FDA Environment
2. Effective organization and planning skills
3. Excellent technical and verbal skills
4. Must have the ability to multi-task
5. Have problem solving skill set
6. Computer knowledge of data collection system and/or spreadsheet software, Microsoft Word, Excel, and PowerPoint
7. Advanced Knowledge and training of cGMP documentation of experiments and Quantitative Analysis.
8. Must be able to work in a cross functional team to investigate root cause for complaints and aid in implementation of corrective actions.

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

For details, visit https://www.virtualfairhub.com/cencora

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned