Supervisor, QC Microbiology

3 weeks ago

Wilmington, United States Alkermes Full time
Job Description

*This position is located in Wilmington, Ohio

Overview:

The Environmental Monitoring Supervisor will be responsible for overseeing the daily operations of a group of analysts on off shift (2nd or 3rd).They will set clear expectations around the delivery of the environmental monitoring and utility work load. The supervisor 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 sampling/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:
  • Provides analysts to support monitoring of manufacturing areas and utilities. Provides support to train manufacturing personnel on water sampling, settle plates, RODAC, and air plates. Work with manufacturing to appropriately schedule work or training. Scheduling coordination with first shift and off shift supervision in EM as well.
  • Write, revise, or review SOP's, environmental and validation protocols, risk assessments, change controls, deviations, controlled forms. Ensure all assigned timelines are met including reviewing, deviations, projects, etc.
  • Participate or lead projects and meetings. Make decisions as needed, involving the manager on critical decisions/projects effecting the overall group or external groups.
  • Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding staff.
  • Maintain aseptic gowning qualification and perform environmental monitoring for each aseptic fill line when analysts need additional support. Act as a backup trainer for EM and Utilities on off shift.
  • Ensure staff is adequately trained to perform job assignments. Execute training in accordance with written procedures and assist in the preparation of training programs and curricula.
QUALIFICATIONS/PERSONNEL ATTRIBUTES
  • Deliver key business messages in a timely manner and support continuous improvement
  • Supportive/Proactive approach to business demands, including bringing solutions to issues identified within the department
  • Ability to work safely; seek out and encourage safe practices, Identify and report unsafe conditions within the laboratory
  • Strong technical knowledge of environmental monitoring and utilities testing (endotoxin, conductivity, bioburden, TOC, MODA)
  • Thorough knowledge of aseptically filled sterile drugs. Additional knowledge of non-sterile solid doses helpful
  • Strong mentor for staff with ability to help others develop and maintain a great team
  • Demonstrate diplomacy and tact to diffuse tense situations and presents arguments to support decision/ point of view
  • Excellent organizational, planning, and scheduling skills.
  • Ability to make decisions efficiently and correctly to align with GMP or SOP requirements.
  • Excellent verbal and written communication skills
  • Maintains a clean, organized lab environment
  • Ability to cope with a rapidly changing work environment
  • Motivates personnel to participate and grow within the department
  • Maintains close oversight of lab operations, training, and the time it takes to complete tasks
EDUCATION AND EXPERIENCE

Education: Bachelor's Degree in a Life Science (Microbiology preferred) with approx. 8 years of experience in pharmaceutical manufacturing or

Associate's Degree in a Life Science field with 8 years' experience and 2 years managing reports in a biology lab

Experience: Prior supervisory/leadership experience (approx. 2 years) managing direct reports and performance reviews in a pharmaceutical or lab setting

WORKING CONDITIONS
  • The successful employee will have the ability to function in a microbiological laboratory and manufacturing environment. The employee should have no inhibitions regarding safely handling microorganisms present in the laboratory and no health conditions/allergies that would prevent them from doing so or conditions which would prevent them from aseptically gowning
  • Employee is required to perform aseptic gowning to support production and investigations as needed. Aseptic gowning must be able to be maintained including an annual requalification
  • Employee must be able to pass a vision exam prior to employment and annually thereafter
  • The employee will be required to be on call for various shifts, weekends, and holidays
PHYSICAL REQUIREMENTS
  • Prolonged periods of sitting or standing.
  • Occasional periods of repetitive motion
  • Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
  • Steel toe shoes, scrubs, safety glasses, and other PPE equipment must be worn based on job being performed.
  • Makeup and Jewelry may not be permitted based on job being performed


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.

#LI-RS1

#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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