Job Title Quality Assurance Tech II Requisition JR000015003 Quality Assurance Tech II (Open) Location St. Louis, MO Additional Locations Job Description Summary The Quality Assurance Technician II performs a variety of review processes with the intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution. This role is also responsible for return good inspections, cGMP area inspections and product inspections. This role ensures QA compliance and that cGMP principles are adhered to. Job Description ESSENTIAL FUNCTIONS : + Execute batch record review and document deficiencies in a computerized system + Identify exceptions and report exceptions to production + Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release + Perform batch record accountability and Iron Mountain box reconciliation + Execute line clearances and assist in inspection of returned goods + Follow all internal and basic cGMP guidelines for pharmaceutical operations + Perform GMP walkthroughs with production on a routine basis + Participate in cross-functional teams to improve review efficiency and support + Adhere to all safety rules and maintain 100% completion of all safety required training + Maintain 100% on time Compliance Wire training MINIMUM REQUIREMENTS : Education: HS Diploma is required; Associates or Bachelor’s degree is preferred. Experience: Minimum of 1-3 years of document review experience in a cGMP environment preferred. Proven knowledge of FDA and cGMP regulations preferred. Proficiency in MS Word and Excel. LIMS, BPCS, and TrackWise experience preferred. Knowledge/Skills/Qualifications: + Ability to communicate at a high level of written and oral skills + Ability to read and comprehend complex calculations and formulas + Ability to focus and review batch records for an extended period of time + Knowledge of cGMPs for APIs + Ability to quickly identify, communicate and/or resolve issues + Ability to read and understand complex batch records + Ability to keep batch records organized and easily retrievable at all times + Excellent verbal and written communication skills + Ability to understand and apply good documentation practices + Ability to build relationships with partners COMPETENCIES: Organizing, Peer Relationships, Functional/Technical Skill, Time Management, Priority Setting, Attention to detail RELATIONSHIP WITH OTHERS: Works with Manufacturing and Quality personnel on a daily basis WORKING CONDITIONS: + 85 % Office environment which includes sitting for long periods of time and computer use. + 15 % Manufacturing environment exposure including temperature, noise, or chemical exposure. 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=)