Quality Specialist II, Process Validation Chemist (On-Site)

Purdue Pharma L.P.•Wilson, NC

3d•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 Performs a variety of chemical analyses and GMP review of raw materials, packaging components, ancillary solutions, in-process samples, finished product and stability samples in accordance with cGMP, GLP, DEA and company policies and procedures. Assists in writing and performing method validations and method transfers. Assists in process validations. Conducts equipment validations IQs, OQs, PQs, and MQs, if necessary. Provides assistance and technical support to other groups with chemical testing needs and performs troubleshooting of analytical methods and instrumentation.

Requirements

The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 2 years minimum relevant experience. Graduate degree (MS Preferred) with one-year minimum experience.
Must demonstrate comprehension of at least two or more analytical technology (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, NIR, IR, or AA/AE); and should have a familiarity with cGMPs and FDA requirements.
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.
Fundamentally understand and use applicable quality systems.
Maintain all accurate regulatory documentation.
Collect data to ensure compliance with applicable GMP, GLP, GCP, GAMP (“GxP”) regulations and internal Standard Operating Procedures (“SOPs”)
Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business.
Maintain current knowledge base in relevant technical discipline.
Each professional must possess effective interpersonal, verbal and listening skills.
Knowledge of and adherence to appropriate laws and regulations are critical.

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.
Responsible for compliance with Controlled Substance documentation and accountability procedures and policies while maintaining high alert to diversion and theft possibilities.
Exercises good judgment in interpreting, understanding context, and reporting data.
Proactively identifies potential problems and recommend solutions.
Prepares, writes, and distributes reports as appropriate.
Participates in preparation and revision of job related controlled documents.
Performs analytical testing of samples under limited direction.
Skilled with laboratory equipment, including routine maintenance and calibration.
Proficient with use and understanding of laboratory chromatography software.
Performs other related assignments and duties as required and assigned.