Job Title

　　Quality Assurance Tech II

　　Requisition

　　JR000013826 Quality Assurance Tech II (Open)

　　Location

　　St. Louis, MO (Pharma) - USA032

　　Additional Locations

　　St. Louis, MO

　　Job Description

　　SUMMARY OF POSITION :

　　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.

　　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.

　　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.