Sr. QA Specialist II Batch Disposition

Job Summary

This position conducts technical quality compliance related activities in accordance with GMP regulations and internal SOP’s. The primary responsibility is to assure compliance to cGMPs, Purdue policies, standard operating procedures, and FDA requirements.

The Senior Quality Specialist II is responsible for dispositioning raw materials, components, and batches. The scope of these responsibilities includes products manufactured by Purdue, Rhodes and 3rd parties. The Senior Quality Specialist II is also responsible for Quality Assurance activities and GMP compliance relating to equipment validation/qualification in support of manufacturing, packaging, and testing of commercial drug products. The Senior Quality Specialist II will also have responsibilities related to QA oversight of the QC Laboratory.

• Review batch documentation and laboratory analysis reports supporting the release of intermediate, bulk, and finished commercial/clinical product. Review documentation and laboratory analysis reports supporting release of commercial raw materials/components. As a result of this review, this position is responsible for making a recommendation based upon such review, for the approval/rejection of the manufactured finished product and/or raw material/component lots for commercial / clinical distribution and/or use.
• Assure proper documentation practices of validation / qualification activities meet current internal SOPs and FDA Regulations during processing.
• Review and approve deviations and investigations for qualification and laboratory activities ensuring appropriate product impact assessment.
• Performing laboratory inspections and data integrity audits.
• Assist/Participate in corporate, regulatory, and internal audits.
• Lead in preparing/revising procedures primarily related to areas of responsibilities to comply with current FDA regulations, cGMPs and alignment of company Standard Operating Procedures.
• Identify improvements for areas of responsibility as well as other Quality System processes to enhance compliance with current FDA regulations, cGMPs and company SOPs while improving operational efficiency.
• Employ risk analysis principles within day-to-day activities and processes.
• Identify opportunities for harmonization of Quality improvements among sites and implement where appropriate.
• Perform other related assignments and duties as required and assigned.

Sr. QA Specialist II

• BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6-10 plus years’ experience or PhD with 3-6 plus years’ experience.

Sr. QA Specialist III

• BS required and 10 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or MS with 8 plus years’ experience or PhD with 4-8 plus years’ experience.

• A thorough understanding and working knowledge of Quality systems and tools.
• Demonstrates working understanding, full knowledge, and ability in primary discipline.
• Apply technical principles, concepts and understanding of systems and procedures.
• Working knowledge of GxP regulations in other disciplines and impact on cross-functional areas.
• Strong organizational skills are necessary to ensure ability to manage several projects and provide appropriate follow-up.
• Must possess knowledge of cGMPs and FDA requirements acquired through experience, training or education as well as excellent written and verbal communication skills.
• High proficiency with software applications like Excel, and Word required and Veeva and SAP a plus.
• Multi-tasking is an essential requirement of this job and thus strong organization skills are required to ensure appropriate tracking, closure, and extension of all tasks as appropriate.

The incumbent will review batch production records and qualification/validation documents which is a regulatory requirement outlined in 21 CFR Part 211. Inadequate review of documents could lead to regulatory citations and could result in products being distributed that do not meet defined…