Our client, a leading pharmaceutical company, is hiring a QA Specialist consultant on a contract basis.
Phoenix, AZ Onsite
The Quality Specialist is responsible for the quality assurance review of documentation related to testing raw materials, packaging components and manufacturing consumables against SOPs, Analytical Methods, and Specifications.
The incumbent will be responsible for the review and approval activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, package and testing of drug products.
Additional responsibilities include but are not limited to, providing quality support to stakeholders and SMEs, reviewing/approving product related GMP documents, releasing incoming materials for use in production, authoring SOPs, adding and removing rejected items from the reject cage, supporting deviations and investigations, supporting change controls for new materials and vendors, reviewing/updating quality agreements/service agreements between the site and vendors and suppliers.
The position will require technical/analytical thinking skills, some technical writing and reading technical reports.
Required Competencies: Knowledge, Skills, and Abilities:
• Basic knowledge of cGMP, ICH, JP, USP and EP
• Ability to multi-task and be flexible
• Strong teamwork skills
• Ability to complete routine tasks with moderate direction
• Ability to follow established procedures and performs work as assigned
• Ability to follow directions and communicate effectively with peers, team and supervisor
• Able to recognize conflict and notify management
• Basic technical writing skills, able to follow technical reports, analytical thinking and reasoning skills
• QA review and approval of all materials specification packages (completed testing, incoming documentation, shipping documentation, etc) for materials used in commercial production.
• Supplier Alert management (submitting notifications to suppliers for non-conformances, reviewing supplier investigations)
• QA review and approval of cGMP documents (SOP, specifications, quality agreements, protocols)
• Quality Agreement (QTA) management
• Provide support for supplier audits and assessment of suppliers
• Adopts and applies Quality Risk Management principles to make sound quality decisions
• Interfaces with all other quality groups within the company on quality systems issues
• Works with other departments to ensure compliance with and understanding of cGMPs,
SOPs, and policies
• Provides QA expertise as a resource to identify gaps, facilitate remedial actions, and ensure
issues are resolved in a compliant manner
• Proposes solutions for issues and works with management to resolve
Education and Experience:
• Bachelors degree preferred
• Minimum of 2 years of relevant work experience required, preferably in quality assurance/quality control
• An equivalent combination of education, experience and training may
• Work is generally performed seated, but may require standing and walking for up to 20% of the time
• Work requires satisfactory completion of an eye examination to demonstrate 20/20 correctable vision
• Work occasionally requires uniform/PPE to work in a manufacturing, warehouse, or laboratory environment