New · posted Nov 6
Cardinal Health · Pharmaceuticals
Sr. Specialist, Quality Assurance (Nights)
- Jackson, MS
- On-site
- Full-time
- Senior & Principal
The role
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.
Schedule: 40 hours per week. This is a night position. Typically, Monday - Friday 12:30 am - 8:30 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.
What you need
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.
- 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 (20%) within the region and network to support other facilities.
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
- Medical, dental and vision coverage
- Paid time off plan
- Health savings account (HSA)
- 401k savings plan
- Access to wages before pay day with myFlexPay
- Flexible spending accounts (FSAs)
- Short- and long-term disability coverage
- Work-Life resources
- Paid parental leave
- Healthy lifestyle programs
Application window anticipated to close: 1/5/2027 *if interested in opportunity, please submit application as soon as possible.
The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.
What you'll do
- Must be willing to train and qualify on GE products.
- Must have experience performing quality control testing on product samples.
- 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
- 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.
Pay and benefits
$59,600 – $76,590 a year
Employer providedAnticipated salary range: $59,600.00-$76,590.00
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Short- and long-term disability coverage
Paid parental leave
Where you'll work
Jackson, MSOn-siteOpen in Maps (opens in a new tab)
More jobs in Jackson, MSEqual opportunity, accessibility and legal noticesCardinal Health's statements, word for word
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
To read and review this privacy notice click here
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 29% below the US median for Quality Operations & Batch Release roles at this level.
This roleEmployer provided
Senior & Principal roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $59,600 | — | $76,590 |
| All US (middle half) | $90,750 | $95,500 | $101,750 |
This role: Cardinal Health's own published range. Comparisons: the base pay employers published on open Quality Operations & Batch Release roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Operations & Batch Release
The general path across 92 open Quality Operations & Batch Release roles on Regulatory Jobs, with the titles they carry most. Not Cardinal Health's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 55 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance7
- Documentation and SOPs7
- Lab testing and methods6
- Quality systems and risk5
- Collaboration and leadership5
- Investigations and CAPA3
- Validation and qualification2
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Operations & Batch Release work in pharmaceuticals, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Cardinal Health on Regulatory Jobs
- 38
- Open roles
- 38
- Distinct roles
- 24
- Locations
By discipline
- Quality33 87%
- Regulatory4 11%
- Clinical1 3%
By level
- Senior & Principal23 61%
- Associate & Specialist8 21%
- Manager5 13%
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Sr. Specialist, Quality Assurance (Nights) at Cardinal Health
Open until filled. $60K–$77K a year, employer provided.