Location: Philadelphia,PA, USA
Permanent, full time role- NIGHT SHIFT 3-4 days a week (6 pm-6 am)
Philadelphia, PA- onsite
Essential Functions and Responsibilities
Supervision and Development of direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.
Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.
Perform review of batch documentation and logbooks for completeness and accuracy.
Author and revise documentation, including drafting and approval of SOPs, Sample Plans, Deviations, CAPAs, etc.
Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
Manage all aspects of QC Sample Management for raw material, in-process, and final product samples including sample storage, sample inventory and reconciliation, scheduling, and shipping.
Maintain sample integrity by ensuring that all samples are managed (i.e., stored; handled; shipped) in compliance with procedures, specifications, and cGMP.
Ensure optimal performance of the QC logistics team through supervision and training.
Ensure optimal vendor performance regarding sample management through adequate oversight.
Provide timely distribution of samples internally and externally to testing vendors.
Ensure that sample inventory records are maintained and accurate.
Create and/or improve procedures to ensure optimal compliance with cGMP.
Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the logistics function remains in compliance with applicable requirements.
Support audits and inspections as needed.
Required Education, Skills, and Knowledge
Minimum Associates degree or at least 5 years of relevant cGMP experience.
Experience supervising a team with direct reports.
Experience with inventory and/or logistics in the pharmaceutical industry.
Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
Hands-on laboratory experience with sample handling, inventory, and cryo-shipping.
Strong collaboration, time management, and organizational skills are required.
Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
Detail-oriented with strong mathematical skills.
Excellent written and verbal communication skills.
Excellent judgment and creative problem-solving skills.
Ability to work successfully in a fast-paced team-oriented environment.
This position is for regular work week hours (M-F); however, due to the nature of cell therapy. manufacturing schedules, must be willing to work weekends, evenings, and holidays, as needed.
Must adhere to core values, policies, procedures and business ethics.
Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies Sample Management methods to fully address compliance issues.
Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation (batch records, deviations, etc.). Strong technical writing ability required.
Experience leading development initiatives, i.e., training, coaching, learning initiatives.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required
Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
Able to stand and/or walk 90% (and sit 10%) of the scheduled workday, which may include climbing ladders or steps.
Must be able to use near vision to view samples at close range.
Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
Must be able to lift and carry objects weighing 45 pounds.
Mental
Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment
This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or change the positions responsibilities at any time.
Pay within this range will be commensurate with level of experience