Mallinckrodt Pharmaceuticals Quality Assurance Specialist (St. Louis MO) in St. Louis, Missouri
Quality Assurance Specialist (St. Louis MO)
JR000008476 Quality Assurance Specialist (St. Louis MO) (Open)
MKG-Hazelwood, MO (675) - USA037
St. Louis, MO
Responsible for providing Quality support for contract manufacturing organizations (CMOs) to ensure compliance with cGMP regulations and procedures. This position supports product development, validation, manufacturing, testing and disposition of investigational and commercial products.
Serves as the Quality lead on assigned projects
Provides guidance, interpretation, support, training and input on cGMP regulations, guidelines, Company procedures and policies
Reviews and/or approves quality documents such as master batch records, validation protocols and reports, quality investigations, specifications, labeling and standard operating procedures
Reviews and dispositions lot batches for drug substances and drug products
Establishes and maintains quality technical agreements between the company and CMOs
Provides support and guidance for technology transfer and validation projects
Plans and performs audits of CMOs, generates reports and tracks actions to closure
Assembles data and provides timely reports to Quality management and project teams
Leads the development and execution of plans to ensure the company and CMOs are ready for pre-approval inspections by domestic and global regulatory authorities
Bachelor’s degree in a scientific discipline
A minimum of 7 years of experience in the biotech or pharmaceutical industry in a similar role
Experience in late-stage development (Phase 3) and product commercialization
In-depth knowledge of current GMP regulatory requirements for the US and other markets
High level of professional integrity and a strong work ethic
Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines
Detailed oriented, with a high degree of accuracy and quality of deliverables
Demonstrated ability to differentiate between critical and minor issues, and work with project teams to identify and implement pragmatic solutions to address them in a compliant mannerOther Skills/Competencies:
Conflict resolution skills.
Strong communication skills
Ability to manage projects involving multiple functional groups without direct report authority
RELATIONSHIP WITH OTHERS:
Reports to Director R&D Quality
Works under self-direction toward predetermined long-range goals and objectives
Determines and pursues courses of action necessary to obtain desired results
Requires minimal direction
SCOPE OF POSITION:
Routine contacts with external customers, multiple site and corporate departments on significant matters requiring coordination between organizations to ensure continuous improvement and implementation of identified projects / system
Office environment and production environment, as necessary to accomplish the objectives of the role as it relates to process knowledge and process improvements.
Travel required (Up to 20% average with higher peaks possible)—both domestic and international
Mallinckrodt is a global specialty pharmaceutical 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.