Job Information
Mallinckrodt Pharmaceuticals Senior Quality Services Coordinator in Port Allen, Louisiana
Job Title
Senior Quality Services Coordinator
Requisition
JR000014105 Senior Quality Services Coordinator (Open)
Location
CC-Port Allen - USA502
Additional Locations
Port Allen, LA
Job Description
The Senior Quality Services Coordinator is responsible for the coordination of the facility’s product complaint program ensuring appropriate evaluations of complaints are performed in a manner compliant with national and international regulations, company policies, and company SOPs.
The Senior Quality Services Coordinator will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, SOP review and revision, trending and reporting, deviation investigation, audit support, and direct involvement and collaboration with the Product Monitoring, Manufacturing, Materials Management, Quality Control, Validation and Engineering groups to drive quality culture.
In addition, the Senior Quality Services Coordinator has project-support responsibilities, serving as a quality representative for both site-specific and company-wide projects.
Essential Functions
Effectively implement and maintain the product complaints program and the quality risk management process at the Port Allen facility
Perform review and approval of OOS, deviation, nonconformance, investigations and Validation/Qualification Records as required
Lead product investigations and corrective action initiatives, as deemed necessary.
Establish, implement, and manage quality standard operating procedures and policies
Perform other tasks as deemed appropriate by management, including but not limited to batch record review and product release, quality systems review and approval, site assessments, and project support.
Conduct investigations, perform risk analysis, and deliver disposition recommendations; assist with writing, revising, and approving standard operating procedures.
Maintain site-specific documentation to comply with company policies, procedures, and regulations; lead continuous improvement activities based on quality metrics.
Participate in auditing activities and serve as SME for regulatory quality services inquiries and documentation requests.
Serve as a QA representative for site and internal company projects; promote the company's vision and values, ensuring safe, clean, orderly, and compliant work areas.
Minimum Requirements
Associate's degree in any discipline with 5+ years of Quality Assurance experience required.
Bachelor's degree in a science/technology discipline with 5+ years of experience in a regulated environment, cGMP preferred.
Proficient in effective interpersonal communication, teamwork, and leadership, with strong organizational skills and attention to detail.
Skilled in written and oral communication, and highly competent in Microsoft Office tools, including Excel, Word, and PowerPoint.
Ability to work independently and be self-motivated
Preferences:
Lean Management, Six Sigma, experience preferredQuality certificate preferred (ASQ CQE, CQM, CQA, etc.)
Working knowledge of Regulations & Compendium Reference Materials and cGMPs
General knowledge of standard quality techniques
Demonstrated abilities in working with Regulatory Agencies in inspections
Organizational Relationship/Scope:
This position reports locally to the Quality Assurance Manager. The Senior Quality Services Coordinator directly collaborates with and supports Product Monitoring, Manufacturing, Materials Management, Quality Control, Validation and Engineering functions. This will be part of the Quality Assurance (QA) Department of the Site Quality Department located at the Port Allen, LA drug and medical device manufacturing facility. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. Additional duties to support functions outside of the Port Allen facility may be assigned.
Working Conditions:
The Senior Quality Services Coordinator typically works in an office setting, with interaction in the manufacturing areas. The hours will consist of one either four 10s or five 8s, depending on need of site.
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Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.