Supervisor, Quality Control (Night Shift)

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Position 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, the establishment of New Product Introduction (NPI's), the 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 areeffectively 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 andmanages the utilization of resources to ensure that departmental objectives are met withinbudget 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 Analyst, Analyst II's.

• Coordinates workflow within their QC team. Directs priorities and testing schedules for staff.

• 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 withbuilding 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 toimprove QC functions.

• May perform testing of high complexity methods.

• May serve as the primary link between the night and day 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.

Hours (Night Shift)

• 6 PM-6 AM

• 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts ove

Minimum Qualifications:

• Significant work experience (ideally in 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.

• Good working knowledge of analytical tests, compendial tests and device testing in a QC environment.

• Strong technical writing and computer skills.

• Previous supervisory or management experience.

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

Sponsorship or support for work authorization, including visas, is not available for this position.

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.