Supervisor, Quality Control

3 weeks ago

Wilmington, United States Alkermes Full time
Job Description

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 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
QUALIFICATIONS:
  • 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
PERSONAL ATTRIBUTES:
  • Communicates well in team settings. Seeks to understand others with diverse viewpoints and expertise. Places high priority on team and/or organizational goals. Begins to build strong relationships with stakeholders external to the Laboratory and takes advantage of these relationships to identify new opportunities
  • Continues to develop knowledge in relevant suite of products or analytical techniques and expands breadth of knowledge to include areas outside of direct function
  • Demonstrates ability to generate and critique high quality / quantity of results from their individual team and present them coherently to an internal and /or external audience
  • Appreciates the organizational vision/ site strategy and understands how the department and team related objectives are aligned
  • Develops objectives for team linked to site strategy and balance and achieve long term objectives with ongoing business demands and priorities
  • Supportive and proactive approach to change in business demands
  • Understand departmental KPIs and their impact on site targets
  • Takes input from others and stimulates open discussions
  • Systematically analyzes successes and failures and uses them as learning experiences
  • Excellent communication and documentation skills
  • Displays an appreciation for the end-goal and can anticipate problems and strategize solutions
  • Displays the appropriate amount of energy and concentration to "stay with the job" and displays the versatility to accommodate changes that might be required to the schedule to ensure all work activities are completed as required
  • 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


Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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#LI-Onsite

About Us

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company 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 neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant 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 class protected by 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.

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