Quality Control Specialist

About the role

Join the Quality Unit in New Albany, Ohio, to ensure products meet company and regulatory standards. This role focuses on continuous improvement and involves inspecting and testing products throughout the manufacturing process. You will support quality operations and report to the Quality Control Manager.

Key facts

What you'll do

• Perform quality checks during and after production, including product assessment in compounding suites.
• Execute line clearance procedures when necessary.
• Conduct AQLs during visual inspection.
• Generate reports and trend data for Quality Assurance management.
• Support departments in reporting, managing, and escalating investigations.
• Assist with non-conformance investigations from external manufacturers to enhance quality processes.
• Manage product retain samples.
• Support the change control system to implement improvement solutions.
• Aid pharmacy quality processes, including inspections, pH and scale checks, non-conformance/deviation/complaint investigations, corrective actions, and training.
• Document and review records such as SOPs, batch records, COA acceptance, and USP monographs.
• Recommend training needs and provide reports to the QC Manager and Lead Pharmacist for compliance.
• Assist with incoming raw material inspections, following guidelines for data collection, testing, and reporting.
• Help draft SOPs and protocols to align with internal global policies, USP, and other regulatory guidelines.
• Ensure compliance with USP <795>, USP <797>, USP <800>, and cGMP cleaning standards.
• Participate in third-party and internal audits to ensure compliance.
• Assist in managing samples sent to contract laboratories for testing.

Requirements

• Bachelor of Science degree in chemistry, microbiology, biology, quality management, engineering, or a related field is preferred.
• 1-3 years of experience in quality assurance/control, process/quality engineering, or product formulation.
• Pharmacy Technician license or commitment to obtain one within six months of hire (company covers costs and trainee hours).
• Experience with aseptic processing and knowledge of ISO 14644.
• Working knowledge of USP-NF standards <795>, <797>, <800>, including monographs.
• Ability to manage multiple tasks simultaneously with strong time management and organizational skills.
• Excellent interpersonal and communication skills, including technical writing.
• Solid understanding of product testing and best practices for testing against specifications.
• Ability to work independently and as a highly motivated self-starter.
• Proficiency with Word, Excel, PowerPoint, and Google platform applications.
• Strong skills in decision-making, data collection and analysis, organizing, and planning.
• Working knowledge and application of statistical analysis, including probability and trend analysis.
• Knowledge and experience in documentation and facility auditing.

Nice to have

• Experience in a 503b outsourcing facility or a cGMP/regulated environment with knowledge of FDA 21CFR 210 and 211.

Skills & tools

• USP-NF standards (<795>, <797>, <800>)
• ISO 14644
• cGMP
• FDA 21CFR 210 and 211
• Microsoft Word, Excel, PowerPoint
• Google platform applications
• Statistical analysis

Practical notes

• This is a day shift position, Wednesday to Saturday, 7:00 AM to 5:30 PM.
• Some travel may be required.
• The role involves working with Hazardous Drugs (HD) and requires wearing Personal Protective Equipment (PPE), including gloves, respiratory protection, and gowns.
• Medical approval to wear respiratory protection (N95, full face respirator, SCBA, PAPR) is required.
• Physical exertion is necessary, including walking up to 50%, standing up to 100%, squatting and bending up to 20%, and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50 lbs.
• Associates must acknowledge understanding of potential risks (teratogenicity, carcinogenicity, reproductive effects) of handling hazardous drugs.
• Benefits include competitive salary and equity, unlimited PTO, company holidays, quarterly mental health days, comprehensive health benefits (medical, dental, vision), parental leave, Employee Stock Purchase Program (ESPP), and 401(k) with employer matching.