Manager Quality Assurance
$100,000–$100,000 year
On-siteIndianapolis, Indiana, United States or Milwaukee, Wisconsin, United States
Job Summary
Establish and implement effective Quality systems to meet cGMP requirements while ensuring the Center remains "inspection ready" at all times. Manage the site Quality Assurance program by conducting routine audits of internal procedures, reviewing batch records for final product approval, and leading investigations to determine root causes and corrective actions. Collaborate with management to resolve non-compliance issues, coordinate Corrective and Preventive Actions (CAPA), and facilitate communication across departments to ensure adherence to Federal, State, and local regulatory laws. Prepare regular reports on the state of quality and systems for corporate management.
Required Qualifications
- Bachelor's Degree
- 7-9 years Minimum of six years QA oversight of biological manufacturing operations, utilizing a risk-based approach to biologic material manufacturing
- Domestic travel (~10%) as needed
- Personal Computer (desk top, lap top, tablet)
- General office equipment (computer, printer, fax, copy machine)
- Microsoft Suite (Word, Excel, PowerPoint)
Desired Qualifications
- Working knowledge and experience practicing under a QMS
- Two or more years performing as a responsible cGMP Quality sign off for a regulated product
- Working knowledge of 21 CFR 210, 211 and 820
- Demonstrated ability to work with remote resources across multiple sites
- Internal and external audit experience, preferred lead audit support
- Previous experience with electronic quality systems such as for document control, training, and change control
- Positive, enthusiastic, and customer service oriented interpersonal skills
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels and establish highly functional relationships within and outside the company
- Excellent technical writing and verbal communication skills
- Strong oral, written and listening skills
- Ability to assess priorities and successfully manage workload to timelines
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Understanding of basic scientific/technical concepts and ability to analyze moderate to complex data and glean basic information from the data
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