Supervisor, Quality Control

Alkermes•Wilmington, OH

21h•Onsite

About The Position

Description Overview: The Quality Control Supervisor oversees the daily operations of a group of analysts, sets clear objectives around the execution and delivery of the QC work load. The Supervisor works cross-functionally with QC management and leaders of other departments to support the commercial release of raw materials and finished products. The supervisor also ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The supervisor is responsible for scheduling personnel and material resources to ensure that testing commitments are satisfied and communicate any difficulties to QC management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor Measures progress, evaluates results, and takes responsibility for outcomes.

Requirements

Bachelor's Degree with 8 years of laboratory experience or Master's/PhD in Chemistry (or related field) with approx. 5 years of laboratory experience.
Prior experience ( approx. 2 to 3 years) of managing direct reports and performance reviews in a laboratory setting.
Demonstrates empathy/ active listening and provide opportunities for individuals to talk freely in an open honest discussion setting.
Demonstrate diplomacy and tact to diffuse tense situations and presents arguments to support decision/ point of view.
Tailors message to audience to motivate and encourage.
Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging and takes actions to overcome likely obstacles.
Ability to lead a Root Cause Analysis exercise either within the department or cross functionally for complex issues.
Capable of identifying the solution and follow through to implementation.
Has the capacity to monitor the effectiveness of preventative measures and continuously improve.
Articulate information clearly- verbally, written, group presentations.
Has the basic awareness to originate action to improve the performance and compliance within the Laboratory.
Uses appropriate methods to identify opportunities, implement solutions, and measure the resultant impact on the operation of the Laboratory.
Recognizes and displays many of the hallmarks of a personally productive individual.

Responsibilities

Supervise testing to ensure compliance with all applicable procedures, and timely completion.
Supervise laboratory investigations.
Train analysts in the investigation process.
Write or review investigation reports and other forms required by the investigation procedure.
Leads specific aspects of a project and guide solutions for difficult problems.
Identify best solutions based on project requirements.
Ensure staff is adequately trained to perform job assignments.
Execute training in accordance with written procedures, this would include but is not limited to training subordinate staff, perform training assessments, document training, assist in the preparation of training programs and curricula.
Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff.
Discuss issues affecting staff, administer attendance policies for non-exempt employees.
Serve on special committees and project teams.
Write, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms.
Review and approve data packages for submission to QA for final disposition.
Serve as subject matter expert on operation and troubleshooting of select laboratory instrumentation.
Identify and report unsafe conditions within the laboratory.
Review technical reports and protocols originating in other departments.
Lead and support improvement projects.
Actively participates and contributes to the Laboratories mission and objectives.
Facilitates dialogue and values input from others.
Deliver key business messages timely.