Quality Assurance Specialist, Stratatech (Madison WI) ST-Madison - USA504/en-US/MallinckrodtCareers/job/ST-Madison---USA504/Quality-Assurance-Specialist--Stratatech--Madison-WI-_JR000008867/apply Job Title Quality Assurance Specialist, Stratatech (Madison WI) Requisition JR000008867 Quality Assurance Specialist, Stratatech (Madison WI) (Open) Location ST-Madison - USA504 Additional Locations Madison, WI Job Description The Quality Assurance Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls. Essential Job Functions: 1. Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.nbsp; 2. Perform internal and external audits as assigned. 3. Review and release raw materials, intermediate products and finished products. 4 Perform review and approval of OOS, deviations, nonconformance, and investigation as required. 5. Ensure systems are in compliance with current SOPs. 6. Assist investigations and resolve potential product quality issues to improve efficiency. 7. Assist with writing, revising, and approving standard operating procedures. 8. Review and approve SOP, protocols and reports as necessary. 9. Coordinate and/or conduct GMP training. 10. May perform additional duties as required. Essential Job Requirements: 1. Bachelors degree in a scientific discipline. 2. At least 2 years experience in cGMP environment within relevant Quality Assurance/Compliance functions. 3. Excellent writing/communication skills. 4. Training experience a plus 5. Ability to travel is required. Principal Responsibilities * Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product * Review and release raw materials, intermediate products and finished products * Coordinate and/or conduct GMP training * May perform additional duties as required * Perform internal and external audits as assigned * Perform review and approval of OOS, deviations, nonconformance, and investigation as required * Coordinate and/or conduct GMP training * Generate, publish, and manage quality systems metrics to drive continuous improvement * Coordinate CAPA, OOS, deviations, nonconformance, and investigations * Assist with revising and developing standard operating procedures * May perform additional duties as required Department specific/Non-essential responsibilities: * Scanning/archiving of GMP documents Minimum Requirements Experience / Skills: * Bachelors, or higher, degree in a scientific discipline, preferable biology or chemistry * 2+ years of experience in a cGMP Quality Assurance/Compliance environment * Excellent writing/communication skills * Proven ability to work independently with little supervision. * Ability to travel is required Competencies: * Proficient with Microsoft Office tools, especially Excel * Technical writing Organizational Relationship/Scope: The Quality Assurance Specialist II collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Clinical Quality, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager.nbsp; It is the expectation this position works during normal business hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing and Lot Release activities. Working Conditions: The Quality Specialist II will mainly work in an office environment but will also be required to work in ISO Class 7 manufacturing and QC environment when providing QA support to those functional areas. #LI-RP1 Posted 7 Days AgoFull timeJR000008867 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:nbsp; 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. nbsp;