Sr. Specialist, Quality Assurance (Nights)

Cardinal Health•Jackson, MS

5d•$59,600 - $76,590

About The Position

Quality Assurance at Cardinal Health develops and implements a compliant, cost-effective quality system to ensure products and services are reliable, safe, and effective. The Sr. Specialist applies knowledge of quality systems, regulations, standards, and operating procedures; performs investigations and root-cause analysis; develops corrective actions; and reviews and dispositions quality documentation. The role also involves interpreting analytical results, assessing gaps against requirements, applying quality concepts, and working cross-functionally to educate and influence others. This is a 40-hour-per-week night position, typically Monday through Friday from 12:30 a.m. to 8:30 a.m. The employee must be flexible to work different shifts or schedules based on business needs, stay until work is completed each business day, and support periodic production hours, which may account for up to 30% of work depending on production needs. Work hours may change. The position also requires travel within the region and network to support other facilities. The role supports product and process quality in a regulated environment. It includes CGMP documentation review and product release, quality metrics and reporting, monitoring corrective and preventive actions (CAPA), aseptic reviews, and collaboration with operations to maintain compliance with 21 CFR 212. The employee must train and qualify on GE products, perform quality control testing on product samples, and maintain proficiency on production qualifications.

Requirements

Bachelor’s degree in a related science field, or equivalent work experience; examples include Microbiology, Chemistry, Biology, or Physics (preferred).
2 or more years of experience in a related science field (preferred).
1–2 years of experience in Quality Assurance and/or a regulated environment, preferably cGMP (highly preferred).
Experience performing quality control testing on product samples.
Effective written and verbal English communication skills.
Ability to lift between 50 and 75 pounds.
Ability to travel 20% within the region and network to support other facilities.
Flexibility to work different shifts or schedules based on business needs and stay until work is completed each business day.
Ability to support periodic production hours, potentially up to 30% depending on production needs.
Ability to manage several tasks simultaneously, focus on tasks, evaluate operating conditions, and exercise sound judgment.
Proficiency with SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook, and Microsoft PowerPoint.
Knowledge of quality systems, relevant regulations, standards, operating procedures, and quality concepts.
Ability to review and disposition quality documentation, perform investigations and root-cause analysis, and develop corrective actions.

Nice To Haves

Pharmaceutical or medical device experience.
ISO experience.
Experience with HPLC, Gas Chromatography, and E-Z Scan radiometric TLC scanner analysis.
Bachelor’s degree in a related science field.
2 or more years of experience in a related science field.
1–2 years of Quality Assurance and/or regulated-environment experience, preferably cGMP.

Responsibilities

Train and qualify on GE products.
Perform quality control testing on product samples.
Apply working knowledge of concepts, principles, and technical capabilities to varied tasks and projects of moderate scope and complexity.
Identify possible solutions to technical problems and take action to resolve them within defined parameters.
Manage multiple tasks, focus on assigned work, evaluate operating conditions, and exercise sound judgment.
Partner with cross-functional teams to meet product and production expectations and demands.
Work periodic production hours to support routine production and testing needs, potentially up to 30% depending on production needs.
Maintain proficiency on production qualifications.
Review CGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production and process controls.
Establish and report product and process metrics as requested by the Regional Quality Manager.
Ensure site manufacturing meets 21 CFR 212 CGMP requirements.
Control, retain, and archive documentation supporting CGMP activities.
Collaborate with Operations to advance quality system and CGMP requirements.
Perform product release activities in accordance with CGMP requirements.
Monitor CAPA investigations and close them when complete or escalate as necessary.
Conduct and document aseptic reviews of the site with Operations.
Report quality system issues and promptly escalate discrepancies to the Regional Quality Manager and others as necessary.
Perform investigations and root-cause analysis and develop corrective actions.
Review and disposition quality documentation, including batch records, environmental monitoring records, validation documentation, change controls, process qualifications, material preparations and acceptance, equipment qualifications and maintenance, and cleaning documents.
Analyze and interpret chromatogram results from HPLC, Gas Chromatography, and an E-Z Scan radiometric TLC scanner.
Conduct gap assessments against applicable requirements and help educate and influence others on those requirements.