Supervisor, QC

Alkermes   •  

Wilmington, OH

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 175 days ago

This job is no longer available.

 Key Duties:

  • Supervise the QC Chemistry data review process to ensure compliance with all applicable regulations and internal procedures.
  • Supervise the QC Chemistry Training Program.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.
  • Supervise the QC Stability Program.
  • Coordinate the completion of laboratory investigations, deviations, corrective and preventative actions, and change controls.
  • Leads specific aspects of a project and guide solutions for difficult problems.Identify best solutions based on project requirements.
  • 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
  • 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

 

Skills/Experience:

  • 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.  Invests upfront in an appropriate amount of preparation for the task in hand, can eliminate the time-wasting activities, takes an ordered and disciplined approach to execution

 

Education/Experience:

  • Bachelors Degree in Chemistry (or related field) with approx. 10 years of laboratory experience, or Masters Degree in Chemistry (or related field) with approx. 8 years of laboratory experience, or 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

 

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