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Quality Assurance Analyst
2 months ago
Kindeva Drug Delivery is a prominent global contract developer and manufacturing organization (CDMO) renowned for its expertise in various delivery platforms, including Autoinjector, Inhalation, Transdermal/Intradermal Patch, and Nasal Spray Technologies. Our Lexington facility specializes in the development, manufacturing, and commercialization of prescription nasal spray products, and is currently experiencing robust growth. We collaborate with our clients to enhance patient outcomes globally.
Compensation and Benefits: This position is full-time and hourly, offering a competitive compensation package that includes health insurance, a 401(k) plan, paid time off, and opportunities for professional advancement.
Position Summary: The role involves ensuring quality oversight and engagement throughout all phases of pharmaceutical development, production, and testing. Responsibilities include reviewing controlled cGMP documentation and manufacturing records, addressing any deviations or out-of-specification (OOS) results that may arise during production, and conducting investigations. The specialist will also participate in the release processes for raw materials, intermediates, and final products, as well as perform internal and external audits of facilities and products.
Shift Details: 3:00 PM - 11:30 PM, Monday to Friday
Key Responsibilities:
- Facilitates the development and upkeep of Quality Systems as required.
- Drives continuous improvement initiatives to ensure compliance with DEA and FDA regulations.
- Advises senior management on findings and recommendations from internal and external audits.
- Oversees the CAPA and Change Control Systems.
- Reviews and approves cGMP documentation, including procedures, batch records, validation protocols, and specifications.
- Develops and maintains metrics and trending reports related to compliance activities.
- Reviews and approves investigations into product complaints and assists in the investigative process.
- Engages in various projects, taking on roles from participant to project manager.
- Collaborates with departments and external suppliers regarding quality-related issues.
- Participates in or coordinates Compliance Assessments as necessary (GXP, Part 11, etc.).
- Supports regulatory inspections and customer audits.
- Assists the Manager with daily and project-related tasks as needed.
- Performs other duties as assigned.
Qualifications:
- Bachelor's degree in a scientific field.
- A minimum of 7 years of experience in Pharmaceutical/Medical Device cGMP quality.
- Familiarity with HPLC principles and the ability to review data for accuracy and completeness.
- Strong problem-solving skills with the ability to identify solutions and implement necessary changes.
- Experience in quality systems auditing (internal and/or external) is preferred.
- Experience in the manufacturing of aseptically filled, sterile products is preferred.
- Advanced understanding of cGMP regulations and validation principles.
- Ability to thrive in a team-oriented environment.
- Excellent communication and technical writing skills.
- Qualified to work with controlled substances.
