Sr. Quality Specialist I, Laboratory Metrology
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.
The Senior Quality Specialist I will administer metrology program, maintain equipment in LIMS, provide schedules for activities, review supplied documentation, author program procedures, and ensure compliance to regulations and written procedures. Will also provide system metrics including usage, downtime, and reliability and develop a system retirement strategy and 5-year laboratory instrument requirements plan.
- Manage projects involving computer system validation as it relates to laboratory systems and the data integrity of electronic data. Work in a cross-functional team on GAMP 5 validation projects to deliver laboratory instrument/software.
- The position requires the Specialist to occasionally move, position, and maneuver equipment weighing up to 50 pounds and remain in a stationary position, often standing for prolonged periods.
- Perform maintenance, calibration, qualification, repair and troubleshooting on a variety of laboratory instruments including but not limited to HPLC, GC, TPW3, Automated Dissolution Systems, UV spectrophotometers, Balances, and pH meters and other special purpose lab equipment.
- Provide time trending and task data; assist with departmental scheduling; manage scheduling spreadsheets to ensure that they are complete and understood and to provide detailed status reports to management.
- Develop, author or revise, and follow strict protocols for instrument installation, operation, and performance qualification.
- Coordination of new instrument installation, calibration and repair with technical groups and vendor; ensure appropriate documentation is in place; communicate with vendors and service personnel regarding instrumentation issues; review vendor qualification protocols and final reports for accuracy, completeness and compliance.
- Assess current vendor calibration programs for performance, applicability and return on investment.
- Assist with assessment of new technology and instrumentation for the labs.
- Assist with laboratory investigations involving equipment failure, including impact assessment.
- Train laboratory personnel or other metrology personnel in metrology activities, as appropriate.
- Maintain the laboratory instrumentation with minimal downtime while adhering to all compliance requirements.
- Implement new instrumentation and new technology in the laboratory including validation and qualification of systems.
- Work closely with users/laboratory colleagues to resolve issues; Assist in setting priorities for problem resolution related to the instrumentation. Assist in investigations, including root cause analysis and CAPA plan.
- Write, revise, develop, evaluate and review Standard Operating Procedures for instrumentation.
- Report system metrics to management
- Perform additional duties as assigned and/or required.
Education and Experience:
Requires at a minimum, a BS degree in Chemistry or other related science with 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.
Necessary Knowledge, Skills and Abilities:
- A successful track record in maintaining instruments is desirable.
- Direct experience in repair and maintenance of laboratory robotics equipment and metrology required for senior level position.
- Must have strong oral and written communication skills.
- The incumbent must be able to clearly identify problems or compliance issues arising from the assigned work and quickly implement solutions.
- Candidate must have a working knowledge of USP, FDA, cGMP, GAMP (particularly V-Model) and 21 CFR Part 11 requirements.
- Hands on experience with documenting user requirements and functional specifications for laboratory instrument/automation systems preferred.
- Knowledge of LIMS, Quality Documentation Systems, Change Control, CAPA Laboratory operations, and Stability programs is highly preferred.
- Knowledge of HPLC, UPLC, Empower CDS, TPW3, MultiDose and other laboratory systems is required.
- Ability to read schematics and perform repairs and maintenance with minimal
Supervisory Responsibilities (if applicable):
This position reports to the Senior Manager Quality Control. This person has no direct reports, however, works in a matrix environment to ensure laboratory equipment reliability, operation and compliance.
Job Titles Supervised:
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
- 4701 International Blvd, Wilson, NC 27893, USA