Sr. Quality Specialist I, Quality Systems (On-site)

Purdue Pharma L.P.•Wilson, NC

10d•Onsite

About The Position

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to 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 through internal research & development and strategic industry partnerships. For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives. We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines. We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue’s Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team! Job Summary Perform a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product samples, and stability samples in accordance with cGMP, GLP, DEA, and company policies and procedures. May author and review protocols for method development, method validation, method transfer, and/or process validation. Execute protocol testing, data review, report writing, and report reviewing. May participate in equipment validation IQs, OQs, PQs, and MQs, if necessary. Provide assistance and technical support to other analysts with chemical testing needs and perform troubleshooting of analytical methods and instrumentation. May be responsible for technical supervision of Quality colleagues and serve as back-up to management to ensure smooth and efficient operation of the lab.

Requirements

The incumbent must have a BA or BS degree in Chemistry or closely related science with six years minimum laboratory experience in pharmaceutical or related industries; or a graduate degree (MS Preferred) with 4-7 years’ experience.
Relevant experience may include academic and/or industry experience and is measured based on the quality and quantity of the experience as it relates to the requirements of the position.
Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, Raman, or IR); and must have a comprehensive knowledge of cGMPs and FDA requirements as well as familiarity with USP and EP monographs.
Effectively identify, describe, and communicate problems and impact in a timely manner.
Routinely participate in problem resolution.
Identify, track, and resolve issues to closure.
Proactively identify potential problems and recommend possible solutions.
Evaluate accuracy, completeness, and adequacy of reports.
Author, revise and annotate job-related controlled documents.

Responsibilities

Perform all assigned testing in a timely and organized manner in accordance with cGMP, GLP, DEA and company policies and procedures.
Accurately document all necessary and relevant information in a clear concise manner as per cGMPs.
Operate and maintain all analytical instrumentation and equipment as per established procedures.
Write, revise, develop and evaluate operational and maintenance procedures.
Communicate openly within the group to provide and gather information, to optimize the use of resources, and to optimize efficiency.
Provide training and assistance to other group members.
Actively participate in investigations, problem solving, and troubleshooting.
Ensure that equipment and working areas are maintained with good safety and housekeeping practices.
Re-stock chemicals and consumables used in analysis.
Prepare and present data summaries (written and oral) as necessary.
Exercise good judgment in interpreting, understanding context, and reporting data.
Proactively identify potential problems and recommend solutions.
Prepare, write, and distribute reports as appropriate.
Participate in preparation and revision of job-related controlled documents.
Perform analytical testing of samples under limited direction.
Support the creation, revision and development of test methods, operational and maintenance procedures, and other job-related controlled documents.
Evaluate accuracy, completeness, and adequacy of reports.
Independently prioritizes workload.
Require minimal guidance and supervision when conducting routine and non-routine activities in primary discipline.
Comply with site and regulatory controlled substance documentation and accountability procedures while maintaining high level to diversion possibilities.
May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
Perform other related assignments and duties as required and assigned.