Quality Associate - Second Shift

Summit Biosciences is a specialized pharmaceutical company that develops, manufactures, and commercializes prescription nasal spray products. Summit Biosciences is experiencing significant growth and 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 in a team-oriented environment. Second shift hours are 3:00 PM - 11:30 PM.

Summit Biosciences is an Equal Opportunity Employer. Summit Biosciences does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by applicable federal, state and local laws. All employment is decided on the basis of qualifications, merit, and business need.

Summary:

Responsible for providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing and testing.  Also responsible for review of controlled cGMP documentation including any OOS that may have occurred during lot production.  Participates during the release of raw materials, intermediates and final products.  Audits documentation, records activities, and keeps management informed on quality issues. 

Essential Duties:

• Supports the development and maintenance of Quality Systems as appropriate.
• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.
• Assists with the CAPA and Change Control Systems.
• Reviews, and approves cGMP documentation including procedures, validation protocols, development reports, specifications and other related documents.
• Develops and maintains metrics and trending reports for Compliance-related activities.
• Reviews and assists in product complaint investigations and assists with investigations.
• 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.
• Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
• Supports regulatory inspections and customer audits.
• Assists Manager with daily and project activities as needed.
• Other duties as assigned.

Qualifications:

• Bachelor degree in a scientific discipline
• At least 2 years cGMP experience
• Knowledge of HPLC principles and ability to review data for accuracy and completeness
• Ability to assess problems, to identify solutions, to plan and implement necessary changes
• Experience in quality systems auditing (internal and/or external) preferred
• Knowledge of cGMP regulations and validation principles
• Ability to work well in a team oriented environment
• Well-developed communication and technical writing skills
• Qualified to work with controlled substances