- Execute and maintain the INCOG material qualification program.
- Develop and maintain material specifications.
- Coordinate and execute material sampling activities, inclusive of physical sampling and testing, sampling for 3rd Party analysis and performing ERP transactions.
- Coordinate and design sampling plans and author and issue certificates of analysis templates.
- Participate in material planning and Ready to Execute meetings to provide updates on material sampling and material release.
- Lead laboratory investigations using troubleshooting tools to identify errors, and exercise rapid decision making to implement corrective actions during OOS/OOT and other non-conformance events.
- Utilize various paper and automated systems (QMS, LIMS, etc.) to manage local QC and site policies, procedures, and technical reports throughout document lifecycles including authoring, reviewing, approving, and retiring.
- Use applied statistics to analyze test results to identify sources of error in laboratory and manufacturing processes. Use data trends to apply a systematic approach to continuous improvement.
- Bachelor's degree in science.
- Minimum of 5 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
- Experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control.
- Experience with statistical sampling and defect criteria establishment.
- First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
- Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, minitab, etc.).
- Experience with AQL establishment with ANSI requirements.
- Experience with defect criteria based on PDA guidance.
- Experience with assembled auto-injector testing based on ISO requirements.
- Previous supervisory experience.
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Incoming Quality Control Supervisor - Fishers, United States - INCOG BioPharma Services
Description
We are seeking an Incoming Quality Control Supervisor that has a passion for leading people and processes, and is familiar with transformational, situational, and servant leadership concepts.
The Supervisor will support continuous personal and professional development of IQC staff through meaningful goal setting, performance management, and career development plans.
The Incoming Quality Control Supervisor will work closely with the Director of Quality Control, QA, SC and MSAT and will lead strategy and direction of the Incoming Quality Control group to partner cross-functionally to identify material sampling needs, physical testing demand, material qualification, developing and maintaining material specifications and deliver solutions for various routine and non-routine processes.
The Supervisor will be influential in championing and developing our Quality Mindset through ingrained quality with skills including attention to detail, on time delivery, and efficiency into the Quality Control organization you will help build.
Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role.
The Supervisor will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners.
The Supervisor will thrive in a team environment but can also work autonomously with strong self-management and organizational skills. Additionally, the Supervisor will possess a demonstrated ability to influence positive outcomes without direct reporting authority.Essential Job Functions:
Special Job Requirements:
Additional Preferences:
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs.
Our culture and priorities are different by design:
focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you.
Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.
We will not tolerate discrimination or harassment based on any of these characteristics.By submitting your resume and details, you are declaring that the information is correct and accurate.
