Quality Specialist III, Chemist
and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.
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 welcome the opportunity to have you on our team!
Our Commitment to Diversity, Equity, Inclusion and Belonging
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy and represent an important component of our goals and objectives. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect is grounded in our Values of Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
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. 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.
- 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.
- 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.
- Supports the creation, revision and development of test methods, operational and maintenance procedures, and other job-related controlled documents.
- Evaluates accuracy, completeness, and adequacy of reports.
- Performs other related assignments and duties as required and assigned.
Education and Experience
The incumbent must have a BA or BS degree in Chemistry or closely related science in addition to 4 years minimum relevant experience. Graduate degree (MS Preferred) with two-year minimum 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.
Necessary Knowledge, Skills, and Abilities
Must demonstrate sound comprehension of multiple analytical technologies (HPLC, GC, Dissolution, Automation, or Spectroscopy – UV/Vis, Raman or IR); and should have a familiarity with cGMPs and FDA requirements. Must pass an internal GMP Training course and be computer literate.
Supervisory Responsibilities (if Applicable)
All Quality Specialist III (Chemist) report to the Team Leader/Manager/Senior Manager. Quality Specialist III (Chemist) may supervise junior staff including temporary staff and interns.
- Ability to independently prioritize workload.
- With minimal guidance and supervision, conducts routine and non-routine activities in primary discipline.
- With minimal guidance and supervision, plans, performs, and reports to management regarding laboratory, quality assurance or compliance activities.
- May interact with other departments/teams within the Company and with external regulatory agencies and business partners.
- Effectively identifies, describes and communicates problem and impact in a timely manner.
- Routinely participates in problem resolution.
- Identifies, tracks and resolves issues to closure.
- Proactively identifies potential problems and recommends possible solutions.
- Evaluates accuracy, completeness and adequacy of reports.
- Authors, revises and annotates job-related controlled documents.
- May train Quality colleagues in processes and procedures.
- May be responsible for technical supervision of Quality colleagues. This may include:
- Assigning work
- Day-to-day supervision
- Input to performance evaluation
- Participating in hiring process
- Organizes and coordinates activities for assigned projects anticipating future needs
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Job Family Quality
- Pay Type Salary
- Travel Required No
- Required Education Bachelor’s Degree
- 4701 Purdue Dr, Wilson, NC 27893, USA