Working at our Company
Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships.
This position conducts technical quality compliance related activities in accordance with GMP regulations and internal SOP's. The Senior Quality Specialist II, Complaints/Batch Disposition is responsible for conducting product complaint investigations and releasing raw materials, components, and batches. The scope of these responsibilities include product manufactured by Purdue, Rhodes and 3rd parties.
The primary responsibility is to assure compliance to cGMPs, Purdue policies, standard operating procedures, and FDA requirements.
Perform complaint investigations for Purdue manufactured products and coordinate/perform complaint investigations for 3rd party manufactured products. Work with supplier quality to obtain required investigative details and complaint approval for 3rd party complaints. Escalate issues as deemed necessary for field action and prepare field alerts as applicable.
Lead in preparing/revising procedures primarily related to complaint investigations and batch review/disposition to comply with current FDA regulations, cGMPs and alignment of company Standard Operating Procedures.
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 distribution and/or use.
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. Assist in implementation of integration with Rhodes Quality organization.
Support Quality initiatives with emphasis on variability/analysis and reduction, process capability, and statistical process control.
Employ risk analysis principles within day to day activities and processes.
Identify opportunities for harmonization of Quality improvements among sites and implement where appropriate.
Education and Experience
BS required; MS preferred
Eight years minimum experience required for BS candidates, six to ten years minimum experience required for graduate degrees (MS preferred), or equivalent level of experience in pharmaceutical or related technical Operation/Quality 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.
Applies 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 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 Trackwise 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 requirement to conduct product complaint investigations is a regulatory requirement as outlined in 21 CFR Part 211. Inadequate complaint investigations could lead to regulatory inspections resulting in regulatory actions such as FDA 483 citations, warning letters, product recall/withdrawal, injunction, etc. The Senior Quality Specialist II, through knowledge and training, will manage these processes to ensure timely completion of thorough complaint investigations.
Supervisory Responsibilities (if Applicable)
Some supervisory experience preferred. Provide oversight of Batch Disposition and complaints as needed during absence of Senior Manager, Batch Disposition.
In addition, the incumbent will review batch production records which is a regulatory requirement outlined in 21 CFR Part 211. Inadequate batch record review could lead to regulatory citations and could result in product being distributed that does 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
Purdue Pharma L.P.