Sr. Specialist, Quality Assurance (P29545)

Cardinal Health•Memphis, TN

About The Position

What Quality Assurance contributes to Cardinal Health Quality Assurance is responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe, and effective. Demonstrates knowledge of quality systems and approaches. Demonstrates an understanding of the relevant regulations, standards, and operating procedures. Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. Demonstrates ability to review and disposition documentation in a timely manner, such as: manufacturing batch records, EM records, validation documentation, change controls, process qualifications, on-site material preparations, equipment qualifications and/or planned maintenance, material acceptance, cleaning documents, etc. Demonstrates proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft Power Point. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. Demonstrates ability to analyze and interpret results from chromatograms by HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner. Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving. Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Production Responsibilities Must have experience performing quality control testing on product samples. Must be willing to train and qualify on GE products. Work in partnership with cross functional teams to ensure product/production expectations and demands are met. Flexibility to work periodic production hours in support of routine production and testing needs, expectations could be up to 30% depending on production needs. Must maintain proficiency on production qualifications. Schedule: 40 hours per week. This is a night position. Typically, Monday - Friday 1:30 am - 9:30 am. Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day. Work hours may be subject to change. Accountabilities Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls. Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM. Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP). Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities. Engages and collaborates with operations department to drive quality system and CGMP requirements. Performs product release activities per CGMP requirements. Monitors CAPA in investigations and closes when completed or escalates (if necessary). Performs aseptic review of the site with operations and documents results. Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification. Qualifications Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred. 2+ years of experience in related science field preferred. 1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMP Pharmaceutical or medical device experience a plus. Effective written and verbal English communication skills. ISO experience a plus Ability to lift between 50-75 lbs. Ability to travel (25%) within the region and network to support other facilities. What is expected of you and others at this level Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks. Works on projects of moderate scope and complexity. Identifies possible solutions to a variety of technical problems and takes actions to resolve. Applies judgment within defined parameters. Receives general guidance may receive more detailed instruction on new projects. Work reviewed for sound reasoning and accuracy. Ability to manage several tasks at the same time; Ability to focus on tasks; Ability to evaluate operating conditions. Ability to exercise sound judgment Personal Protective Equipment sound reasoning and accuracy

Requirements

Bachelor’s degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred.
2+ years of experience in related science field preferred.
Effective written and verbal English communication skills.
Ability to lift between 50-75 lbs.
Ability to travel (25%) within the region and network to support other facilities.
Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks.
Works on projects of moderate scope and complexity.
Identifies possible solutions to a variety of technical problems and takes actions to resolve.
Applies judgment within defined parameters.
Receives general guidance may receive more detailed instruction on new projects.
Work reviewed for sound reasoning and accuracy.
Ability to manage several tasks at the same time
Ability to focus on tasks
Ability to evaluate operating conditions.
Ability to exercise sound judgment

Nice To Haves

1-2 years of experience in Quality Assurance and/or regulated environment highly preferred – cGMP Pharmaceutical or medical device experience a plus.
ISO experience a plus

Responsibilities

Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
Engages and collaborates with operations department to drive quality system and CGMP requirements.
Performs product release activities per CGMP requirements.
Monitors CAPA in investigations and closes when completed or escalates (if necessary).
Performs aseptic review of the site with operations and documents results.
Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.