Mallinckrodt Pharmaceuticals is a multibillion dollar specialty pharmaceutical company focused on our mission:Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, stemming from 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future.
What We Do:
Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients. Mallinckrodt’s growing portfolio of specialty pharmaceuticals help treat a wide variety of health conditions. We invest in areas such as autoimmune and rare diseases; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products. To see what sets Mallinckrodt apart, take a look at our distinctive approach to solving complex challenges with unique solutions.
What We Believe In:
People throughout the world count on Mallinckrodt products every day to help them lead healthier lives. That’s why we proudly stand by the three values we have held for 150 years: to produce quality products with the utmost integrity and unparalleled service in order to better serve the patients, customers, and communities in which we live and work. Explore the roles of our dedicated employees and our commitment to responsibility.
At Mallinckrodt Pharmaceuticals, our five Cultural Hallmarks guide our work and serve as a foundation for our success. Employees are Accountable, Competitive, Collaborative, High Performing, and Trustworthy.
Job Description
The Environmental Monitoring Supervisor serves as the program owner for the Environmental Monitoring (EM) program. This position provides subject matter expertise to the EM team and manages the EM group and compliance activities to achieve key site and corporate objectives.
- Manages the hiring, training, and performance management of EM personnel.
- Provides subject matter expertise and assistance to the EM program.
- Manages the EM group to achieve compliant testing in a timely manner.
- Manages EM investigations and drives any corrective actions.
- Owns the EM program and ensures that all tracking, trending, and reporting of the EM data is completed.
- Provides overall leadership to EM group regarding cGMP compliance improvement and enhancement.
- Drives Quality consistency through reviewing/revising various EM SOPs to ensure adequacy under normal EM conditions.
- Works with other Managers/Supervisors and EM technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations.
- Acts as a liaison between EM, QC, manufacturing, and cleaning to ensure compliance to the EM program.
- Performs as a subject matter expert during audits.
- May perform environmental monitoring sampling according to Standard Operating Procedures (SOPs) when necessary.
- Understands and utilizes EM sampling equipment and techniques as necessary (total airborne particulate, viable airborne, viable surface, and viable personnel monitoring).
- Follows cGMP and GDP to perform all tasks.
- Develop and coach to build talent.
- Prioritizes and plans workload and team assignments to meet all internal needs for maximum efficiency and accuracy.
- Effectively trains others in a positive manner.
- Additional duties as assigned.
Qualifications
Experience / Skills:
- Bachelor’s degree in a scientific discipline with at least 8 years of related experience is required. Previous supervisory experience is preferred.
- Strong knowledge of cGMP is required.
- Experience in clean room environmental monitoring and aseptic technique is required.
- Action oriented/drives for results.
- Excellent communication and interpersonal skills.
- Team orientation/strong team player.
- Ability to coach, mentor, and teach.
- Excellent decision-making, problem-solving, and analytical skills.
- Detail-oriented with the ability to work under tight deadlines.
- Builds positive relationships with others.
- Excellent time management and prioritization skills.
- Excellent technical writing skills.
- Knows the difference between managing and leading and when to apply each.
Additional Information
Organizational Relationship/Scope:
- Reports to QC Manager, Director of Quality.
- Work is performed without appreciable direction.
- Works with QC Manager to develop strategic objectives for the group managed.
- This position has several EM direct reports.
Working Conditions:
- 75% normal office and meeting room conditions.
- 25% laboratory and manufacturing environment.
- Must be able to wear the appropriate personal protective equipment (PPE) necessary.
- Some off-shift and weekend work may be required.
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