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.

Primary Responsibilities

• 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.

Education and Experience Requirements

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.

Necessary Knowledge, Skills, and Abilities

• 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 compliance standards. The incumbent will:

• Provide in-depth analyses and recommendations to senior management in complex and ambiguous situations across the organization.
• Help management team to meet day-to-day assignments
• Demonstrate ability to manage resources and workload.
• Demonstrate initiative in the timely resolution of problems.
• Demonstrate ability to manage projects and identify resource needs.
• Demonstrate excellent understanding of cGMPs, FDA regulations, and pharmaceutical manufacturing processes

Supervisory Responsibilities (if Applicable)

Some supervisory experience preferred. Provide oversight as needed during absence of Senior Manager.

Physical and Environmental

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching. While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax or other specialized equipment used in an office setting.
• Individual may move various items (i.e boxes, carts, files, etc) by hand or manual hand carts.
• Must be able to work 10.5 hours per day/4-day work week; 40 hours per week.

Additional Information

Relocation is not offered for this position.

Purdue Pharma does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.

Minimum required education, experience, knowledge, skills and abilities for Senior Manager Operations are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.