Description
The Quality Validation Specialist will help implement Quality procedures and standards throughout the stages of drug product manufacturing, packaging, and release.
The Quality Validation Specialist will provide support with:
•Lifecycle Document Review/Approval
•Protocol Review/Approval
•Summary Report Review/Approval
•Change Control Review/Approval

Working closely with the Manager of Quality Assurance for Quality Control, the Quality Validation Specialist will be instrumental in ensuring site compliance with Regulations, Industry Standards (e.g. ISPE, PDA, ASTM), and organizational SOPs. They will also be key in championing and developing the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The Quality Validation Specialist will at all times provide support with identifying and closing Operational and Quality gaps.
The Quality Validation Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The Quality Validation Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Quality Validation Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The Quality Validation Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
Essential Job Functions:
•Review documentation for compliance and Quality approval, including but not limited to: equipment and software (process equipment, computerized systems, facilities, utilities, laboratory equipment as needed) commissioning, IQ/OQ/PQ protocols and reports, equipment and software validation lifecycle documents (e.g. URS, TM, etc.), cleaning validation protocols and reports, and process validation protocols and reports.
•Provide Quality oversight to the periodic qualification evaluation (PQE) program to ensure timeliness of execution and documentation completion.
•Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.
•Ability to manage multiple projects in a fast-paced environment.
•Provide support during normal hours (8 AM - 5 PM Monday-Friday) and after business hours as needed.
Special Job Requirements:
•Bachelor's Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
•Minimum of 2 years of biopharma industry experience with increasing responsibilities in Commissioning, Qualification, and Validation.
•Excellent written and verbal communication skills.
•General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
Additional Preferences:
•Experience with executing or providing oversight for CQV activities for FDA/EMA regulated facilities.
•Experience with CQV activities for aseptic manufacturing facilities or clean utilities (e.g. Water for Injection, Clean Steam, etc.).
•Experience utilizing electronic validation execution systems (e.g. KNEAT, ValGenesis).
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.