Supervisor, Quality Control

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Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Job Summary

The Supervisor, Quality Control is responsible for the analytical quality control of pharmaceutical manufacturing for West Chester products and other products manufactured by contract manufacturers. This also includes establishment of New Product Introduction (NPI's), technology transfers, analysis of raw materials and/or the analytical support for investigations within West Chester Quality Control. As a member of QC leadership, the Supervisor, Quality Control, will also be responsible for delivering QC and site Quality priorities and initiatives as appropriate, collaborating with manufacturing, supply chain and planning teams to deliver the site priorities.

Position Responsibilities:

• Ensures that systems and processes owned by their team are in a state of control, and are effectively managed and maintained.
• Assigns responsibilities to ensure that workload is managed within their team, ensuring effective use of resources.
• Assigns and manages roles and responsibilities within their team to ensure clear accountabilities and high-level performance, that meet or exceed customer needs.
• Allocates team staffing and manages the utilization of resources to ensure that departmental objectives are met within budget guidelines.
• Maintains a safe work environment by ensuring that team personnel follow site EHS policies and procedures.
• Develop and maintain a high performing team of Senior Analysts, Analyst I & II's, and QC technicians.
• Coordinates workflow within their QC team. Directs priorities and testing schedules for staff to ensure timely release of batches.
• Utilizes Lean concepts to drive improvements.
• Identifies and implements learning and development programs for team members.
• Ensures that team skills, knowledge, and experience are appropriate and well balanced to meet team needs.
• Provides feedback to their team, and to other teams that interact with team, to assist with building improved performance.
• Answer compliance and process questions from others, including regulatory agencies.
• Communicate policies and procedures to employees.
• Lead process improvement activities and teams to meet strategic goals including Lean labs and High Performing Labs.
• Communicate priorities and progress to team on a continuing basis.
• Ensure that employees have the tools needed to perform their jobs safely.
• Monitor training of employees to ensure compliance.
• Facilitates and leads initiatives using new technologies, new policies, or new procedures to improve QC functions.
• May perform testing of high complexity methods.
• May serve as the primary link between the night, day and weekend shift QC teams.
• May serves as the primary link between production and QC teams.
• Other duties that support Operations, or Laboratory processes may be assigned.
• Train others on procedures, and/or processes.
• Review, verifies and approves QC data while monitoring for trends and abnormalities.
• May serve as QC lead for investigations involving PET process areas related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling and testing.
• Support transfer, development and qualification of new methods and processes.
• Own, assess or be a SME for the change management processes for new lab equipment, method updates or specification changes.
• Author, Review, Approve various QC documents, including but not limited to work instructions, SOP's, forms, logbooks, reports, method transfers, validation plans.
• Serve as Business Process Owner for some laboratory instruments, shared responsibility across the Supervisors in QC.

Minimum Qualifications:

• Significant work experience within a cGMP environment in an analytical laboratory
• Demonstrated leadership and management skills
• Ability to read, understand, and execute instructions in accordance with SOPs, and other documentation
• Good interpersonal and communication skills, including ability to teach and instruct, and ability to resolve conflict
• Individual must be self-motivated, highly organized and able to work in a fast-paced manufacturing and testing environment

Preferred Qualifications:

• Bachelor's degree Chemistry, Biochemistry, Biology, Life Sciences
• Strong working knowledge of Global Regulations, various compendia and cGMPs.
• Previous experience as a people leader of highly skilled analysts.
• Good working knowledge of analytical tests, compendial tests and device testing.
• Strong technical writing and computer skills.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.