Job description
Nature and Scope
The primary responsibility of the Manufacturing Quality Analyst is to assure timely and accurate completion of Corrective Actions or Preventative Actions (CAPAs). This position will organize and communicate CAPAs between Manufacturing, the Process Investigations Team, and CAPA Management as well as bring visibility to open CAPAs as they relate to priority for manufacturing. This individual will take a scientific and risk-based approach to exemplify unwavering commitment to product quality and patient safety.
Essential Duties and Responsibilities
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Initiate and complete or assign CAPAs related to Manufacturing departments (Formulation, Equipment Prep, Sterile Filling, Autoclave, Inspection, Packaging, Facilities and Engineering).
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Technical writing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOPs), CAPAs, change controls, risk assessments, protocols, batch records and white papers.
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Review of product support documentation (e.g., batch records, process validation, work orders and logbooks).
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Initiate and complete or assign CAPAs to resolve and prevent recurrence of events.
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Utilize project management tools to drive critical CAPAs and their associated work to effective and timely completion.
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Act as liaison between Manufacturing and Quality including CAPA Management for the acceptability and timeliness of CAPAs.
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Present completed CAPAs to CAPA Management for review, reconciling feedback to facilitate final approval.
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Facilitate, track, and trend all Manufacturing CAPAs included related protocols and change controls.
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Support Manufacturing and Quality departments to assist in data collection activities and prepare necessary documentation, as needed.
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Assist Manufacturing personnel as needed to assure CAPAs are conducted according to established standards and remain compliant.
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Support data tracking and metrics for Manufacturing CAPAs.
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
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Bachelor’s Degree in a science discipline, Engineering or related field, required. Candidate with equivalent years of experience will be considered.
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Minimum of 2-5 years’ experience with sterile manufacturing and/or Quality Systems, required.
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Superior technical writing, critical thinking, and problem-solving skills, required.
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In-depth knowledge of CAPA documentation procedures and requirements, required.
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Strong oral, written, communication, presentation, and interpersonal skills. Capable of interfacing with multiple levels of people within the organization, including corporate management, third party customers, and plant personnel, required.
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Experience organizing data from multiple sources, extracting key information and completing CAPAs in a timely manner, required.
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Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, PowerPoint, Outlook, etc.), required.
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Experience working in a cross-functional, matrix environment to drive projects to completion.
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Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
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Experience in a pharmaceutical industry, preferred.
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Experience in TrackWise, preferred.
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Working knowledge of environmental monitoring and aseptic manufacturing, preferred.
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Understanding of Six Sigma Basic Principles, preferred.
Physical Environment and Requirements
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Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
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Employee must be able to occasionally lift and/or move up to 15 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make
https://americanregent.com/Careers
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email
hrtalentacquisition@americanregent.com
.
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