Qa Specialist Jobs

Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences offers competitive compensation + annual bonus, 401k plan, paid holidays, PTO, health/dental/vision/life insurance, short/long term-disability, an incredible collaborative and challenging culture.

The QA Specialist is responsible for providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing. Also responsible for review of controlled cGMP documentation and manufacturing records including any deviations or OOS that may have occurred during lot production as well as investigations. Participates during the release of raw materials, intermediates and final products. Performs internal and external audits of facilities and products, observes critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.

Essential Duties:

• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
• Other duties as assigned.
• Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
• Advises senior management on findings and recommendations related to internal and external auditing.
• Performs activities associated with various one-time or on-going projects (from participation level to project manager).
• Collaborates with departments and external suppliers regarding quality concerns.
• Assists Manager with daily and project activities as needed.
• Manages the CAPA and Change Control Systems.
• Reviews and approves product complaint investigations and assists with investigations.
• Supports regulatory inspections and customer audits.
• Supports the development and maintenance of Quality Systems as appropriate.
• Develops and maintains metrics and trending reports for Compliance-related activities.
• Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents.

Qualifications:

• At least 7 years Pharmaceutical/Medical Device cGMP quality experience
• Advanced knowledge of cGMP regulations and validation principles
• Bachelor degree in a scientific discipline
• Experience in quality systems auditing (internal and/or external) preferred
• Qualified to work with controlled substances
• Ability to assess problems, to identify solutions, to plan and implement necessary changes
• Experience in manufacturing aseptically filled, sterile products preferred
• Well-developed communication and technical writing skills
• Knowledge of HPLC principles and ability to review data for accuracy and completeness
• Ability to work well in a team oriented environment