Job Title Quality Analyst II Requisition JR000014866 Quality Analyst II (Open) Location Raleigh, NC Additional Locations Job Description Summary Job Description SUMMARY OF POSITION: The Quality Analyst II has responsibility for Product Release and Maintenance of Monthly Quality Metrics and Daily Notification to Management. They provide support for customer inquiries, gap assessments, batch record review, and label preparation as assigned. ESSENTIAL FUNCTIONS: + Utilize inventory management systems and other associated quality systems to ensure proper release of product for the Raleigh manufacturing site. + Function as a Primary back-up for the Raleigh site gap assessments and customer inquiries and coordinates organization of required documentation for GMP customer requests with guidance from manager. + The role will provide support for various elements of Quality including but not limited to the following: Annual Product Review, Management Review, Audits, Product Complaints, CAPA, and Change Control. ADDITIONAL FUNCTIONS: + Function as a secondary back-up for batch record reviews. This includes providing timely and thorough audits of all product batch records to ensure site compliance with cGMP regulations, picking up all batch records to be audited from the plant and returning all audited records to the plant (minimum is once daily but could require multiple trips), and providing batch record training as needed for all production employees and potential new QA Analysts. + Function as primary back up for label preparation. This includes programing label changes and add new codes to the labeling computer. Makes, proofs, and records all finished lot labels to meet the production schedule and as requested by production personnel. Issuing final product labels and batch records to production. + Assist as needed with archival of batch records to including but not limited to, batch record scanning, documentation error tracking and corrections, and label reconciliation. + Performs administrative activities for the Quality department. This includes ordering supplies and other materials for both, QA, and QC as well as filing. + Provide support to investigations, both exceptions and OOSs, to support product disposition. + Provide support to intermediate labeling and tank inspections as needed. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation. + Participates in a certified 5S Workplace System to ensure good housekeeping and organization. + Provide administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines. MINIMUM REQUIREMENTS: Education: High School Diploma, GED, or equivalent. Associates or Technical degree or higher preferred. Bachelors or Sciences (BS) or equivalent life science degree preferred. Experience: Competency in MS Word, Excel, and Adobe is required. 1-3 years pharmaceutical manufacturing experience preferred. Preferred Skills/Qualifications: Other Skills/Competencies: Organization, follow-through, effective communication, and computer literacy. Requires basic knowledge of quality procedures and GMP to appropriately perform functions associated with site compliance to FDA regulations. Diligence, organization, time management, and effective communication are needed for this position. A high degree of concentration is required to prevent mix-up and consequent quality release errors. RELATIONSHIP WITH OTHERS/ SCOPE: + This position reports Quality Manager and indirectly to the Site Quality Director + Ability to understand the timely nature of work, quick reporting of results, and fast changing of priorities are necessary to complete assigned tasks. + This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt. + No employees directly reporting to this position. + This position requires self-motivation and daily execution of tasks with limited supervision interaction. WORKING CONDITIONS: + General normal office and meeting room conditions but must complete some routine assignments in plant and non-air-conditioned production environment. + Ability to adjust schedule as needed to assure early week shipments. + Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses and any other devices or equipment as specified for the position. DISCLAIMER: The above statements are intended to describe the general nature and level of work being 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. At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let’s do something dynamic together. Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)