Quality Associate - Second Shift

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:

• Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
• Performs activities associated with various one-time or on-going projects (from participation level to project manager).
• Supports the development and maintenance of Quality Systems as appropriate.
• 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.
• Collaborates with departments and external suppliers regarding quality concerns.
• Other duties as assigned.
• Reviews and assists in product complaint investigations and assists with investigations.
• Assists Manager with daily and project activities as needed.
• Assists with the CAPA and Change Control Systems.
• Supports regulatory inspections and customer audits.
• Leads continuous improvement objectives to assure compliance with DEA and FDA regulations.

Qualifications:

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