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.

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.

Qualifications:

• 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. 

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About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023). 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law.  Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Alkermes is an E-Verify employer.