Shire Jobs

POSITION SUMMARY

Alkermes is seeking an experienced individual to supervise the Quality Control Raw Material Chemistry team based at the Wilmington, OH location. The Quality Control Raw Material Supervisor oversees the daily operations of a group of analysts and sets clear objectives around the execution and delivery of the QC workload. The Supervisor also ensures that all activities within the laboratory are performed in compliance with cGMP, UPS/EP/JP compendia, 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 or delays 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.

 * Major Duties/Responsibilities*

• Supervise testing to ensure compliance with the USP/EP/JP and with all applicable procedures and completed within a timely manner to meet established cycle times. 
• Supervise laboratory investigations.  Train analysts in the investigation process.  Write or review investigation reports and other forms required by the investigation procedure. 
• Serve on special committees and project teams. 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  
• Write, revise or review SOPs, analytical protocols, analysis reports, specifications, and controlled forms 
• Review and oversee implementation of any compendial updates as required
• Author, review, and/or approve method validations, verifications, including any verifications to compendial methods.
• 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 and provide input and support to rectifying the unsafe conditions. 
• 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
• Author, assess, or approve change controls

SKILLS/EXPERIENCE:

Proficient in the use and understanding of compendia (USP/EP/JP)

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 d