Job description
Under minimum supervision of QC Management, provides leadership in, and assists with analytical method transfer, method optimization support, and scheduling program for release and/or stability. Supervises special testing studies of an experimental, investigative, and problem-solving nature. Assists QC Management with laboratory investigations. Participates in, examines, and solves technical problems associated with the manufacture, handling, and storage of pharmaceutical products. Identifies and supports improvements in analytical testing methods, equipment, procedures, control systems and laboratory workflows. Supervises and mentors laboratory analysts as needed.
Essential Duties and Responsibilites
- Supports laboratory management in scheduling priorities and workload allocations of multiple project assignments within the laboratory for their team to ensure data quality standards and deliverables are met.
- Supervises Laboratory team members and mentors to provide on-going training to enhance efficiency, increase technical skills and understanding of cGMP requirements. Provides routine feedback to QC Management in support of developing a robust and comprehensive training program.
- Reviews and provides feedback to management on method transfers or method revisions to QC Management. Provides feedback on and supports optimization, and re-development/validation design of effective analytical methods using guidelines from USP and ICH.
- Provides leadership for and conducts development of laboratory process maps and/or workflows for their team’s assigned responsibilities. Supports the planning and execution of identified improvement opportunities to create more efficient workflows.
- Under guidance of QC and QA management, executes laboratory investigations in a timely fashion.
- Executes laboratory regulatory and 5S/6S audits to maintain proper audit readiness. Ensures QC lab staff are properly documenting laboratory activities, following all appropriate SOPs, and filing data using appropriate logbooks, records, files, and equipment calibration logs. Responsible for remediating or coordinating with QC Laboratory Management staff as appropriate, to ensure identified gaps are remediated in a timely fashion.
- Enforces safety rules and assists in keeping the laboratory compliant in accordance with cGMP and OSHA Laboratory Standards requirements.
- Assists in hiring, performance review, and disciplinary actions of the employees under his/her supervision.
- Enforces execution of continuous improvement ideas generated by management in support improving or remediating trends identified in QC laboratory metrics. Uses experience to help generate ideas focused on improvement of metrics-denoted problem areas within the laboratory.
- Ensure proper analyst operation of laboratory equipment such as, but not limited to, HPLCs, GCx, balances, pH-meters, hardness testers, and dissolution baths in the performance of required and scheduled test procedures and in accordance with laboratory SOPs.
- Audits, as necessary, team’s work prior to submission to quality assurance and remediates any identified gaps
- Supports QC laboratory inventory management process to minimize negative impact to laboratory operation. Ensures continuous flow of all materials through the lab.
- Maintains professional and scientific competence in pharmaceuticals testing by reading scientific literature and/or attending seminars, training sessions, workshops, or classes.
- Performs other duties as required.
Education/Experience:
Bachelor’s degree in laboratory-related scientific field with at least 10 years of pharmaceutical laboratory experience. Advanced degree and prior supervisory experience preferred. Equivalent combination of education and experience or training is acceptable.
To apply, send resume and salary requirements to:
humanresources@upm-inc.com
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