Job Title

Quality Assurance Intern

Requisition

JR000014824 Quality Assurance Intern (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

The Company
Mallinckrodt is a company united around a central pursuit – improving outcomes for underserved patients with severe and critical conditions. As a purpose-driven organization with a broad network and relentless determination, we create products, delivery systems and solutions for patients whose needs have not been met.

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty and generic pharmaceutical products and therapies. With locations in the US, Canada, Europe and Asia, culture is one of the most important aspects of our organization. Who we are at the core of our company - how we think, feel and work together means everything. We are anchored in our values of Patient Centricity, Innovation, Collaboration, and Integrity.

The Company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. We are focused on listening to needs and delivering solutions. We provide medicines to address unmet patient needs, stemming from 155 years of using our unique strengths, experience, and expertise to help improve people's lives.
We know that we contribute to something that matters because we make quality products that impact patient lives. We have built an inclusive community and recognize the importance of every employee as a whole person – inside and outside of work. Our dynamic work environment provides unique experiences for employees to grow and develop.

We are moving forward – come with us.

Job Description

Summary

The Quality Assurance Intern is responsible for maintenance of the Quality Management Systems within the College Park manufacturing facility.  This position will have a wide range of tasks which include supporting performance of investigations related to deviations, nonconformances, and out-of-specification/out-of-trend events.  The Quality Assurance Intern will also support the corrective and preventive actions that are identified as a result of those investigations. This individual is responsible will support the trending and metric reporting of the quality management system elements at the College Park manufacturing facility. 

Principal Responsibilities

Help perform and evaluate trending of the Quality Management Systems to support management reviews, investigations, and continuous improvement initiatives (i.e. quality management reviews, annual product quality reviews, trend analysis for quality events, etc.)Interpret and properly apply all applicable regulatory requirementsSupport investigations through cross functional team involvement (i.e. RCA, etc.)Improve existing procedures or create new procedures to align with cGMP and regulatory requirementsReview procedures, protocols, reports, etc., as requiredAssist with continuous improvement, compliance-based, and site projectsSupport lean manufacturing initiatives both at the site level and within the greater Quality/Operations organizationParticipate in internal audits as a SME or member of the audit teamPerform additional duties as directed by managementSupport the day to day management for QA Team and associated workload.

Department specific/Non-essential responsibilities:

Support other Quality functions at the site through cross-training opportunitiesHelp drive Continuous Improvement projects on site from a Quality PerspectiveEnsure Compliance with current regulatory requirements

Minimum Requirements

Experience / Skills:

Bachelor’s degree or higher in a scientific discipline (biology, chemistry or engineering)Effective communication and presenting skillsAbility to manage changeSelf-motivated Independent and sound decision making capabilitiesTeam-orientedDeliver on-time results / Time Management

Competencies/Certifications:

Proficient with the Microsoft Office Suite, especially Excel, Word, and PowerPoint

Organizational Relationship/Scope:

The Quality Assurance Intern collaborates closely with Manufacturing, Quality Control, EHS, Engineering, and Maintenance.  This individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position’s working hours are during normal site hours M-F, but may be required to work extra hours or on weekends or holidays in order to support site activities.  This position reports directly to the Lead, Quality Assurance. 

Working Conditions:

The Quality Assurance Intern will mainly work in an office environment but will also be required to work in the manufacturing and QC environments when providing QA support to those functional areas.

Disclaimer:

The above statements are intended to describe the general nature and level of work be

ing performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.