FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures). * Data Integrity principles ... Tunnell employees and/or contractors are expected to comply with all client requirements, including ...
Quick apply
FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures). * Data Integrity principles ... Tunnell employees and/or contractors are expected to comply with all client requirements, including ...
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FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures). * Data Integrity principles ... Tunnell employees and/or contractors are expected to comply with all client requirements, including ...
Dublin, OH · On-site
Manage contractor and vendor relationships, service agreements, permits, and project execution ... Knowledge of FDA, GMP, ISO, OSHA, and other applicable regulatory requirements. * Ability to manage ...
Dublin, OH · On-site
Manage contractor and vendor relationships, service agreements, permits, and project execution ... Knowledge of FDA, GMP, ISO, OSHA, and other applicable regulatory requirements. * Ability to manage ...
Manage contractor and vendor relationships, service agreements, permits, and project execution ... Knowledge of FDA, GMP, ISO, OSHA, and other applicable regulatory requirements. * Ability to manage ...
Manage contractor and vendor relationships, service agreements, permits, and project execution ... Knowledge of FDA, GMP, ISO, OSHA, and other applicable regulatory requirements. * Ability to manage ...
Own and oversee onboarding, certification, and annual recertification for all Medical Affairs personnel (FTEs and contractors). * Ensure alignment with FDA/FDCA, OIG/DOJ, PhRMA Code, Sunshine Act ...
Own and oversee onboarding, certification, and annual recertification for all Medical Affairs personnel (FTEs and contractors). * Ensure alignment with FDA/FDCA, OIG/DOJ, PhRMA Code, Sunshine Act ...
Coordinate contractors, vendors, and service providers to ensure safe, timely, and cost-effective ... Ensure projects and facility operations comply with OSHA, EPA, FDA, BRCGS, and applicable local ...
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Coordinate contractors, vendors, and service providers to ensure safe, timely, and cost-effective ... Ensure projects and facility operations comply with OSHA, EPA, FDA, BRCGS, and applicable local ...
$67K - $91K/yr
Coordinate contractors, vendors, and service providers to ensure safe, timely, and cost-effective ... Ensure projects and facility operations comply with OSHA, EPA, FDA, BRCGS, and applicable local ...
Quick apply
$67K - $91K/yr
Coordinate contractors, vendors, and service providers to ensure safe, timely, and cost-effective ... Ensure projects and facility operations comply with OSHA, EPA, FDA, BRCGS, and applicable local ...
Columbus, OH · On-site
$20 - $27.50/hr
Maintain equipment in compliance with FDA, DEA, and OSHA standards . * Monitor the performance of contracted services such as pest control, cleaning, waste removal, and equipment calibration.
Columbus, OH · On-site
$20 - $27.50/hr
Maintain equipment in compliance with FDA, DEA, and OSHA standards . * Monitor the performance of contracted services such as pest control, cleaning, waste removal, and equipment calibration.
Ensures compliance with all applicable FDA Food Code, ODH, and licensing requirements, including food safety, sanitation, and documentation standards. * Manages the Agency's contracted Environmental ...
New
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Ensures compliance with all applicable FDA Food Code, ODH, and licensing requirements, including food safety, sanitation, and documentation standards. * Manages the Agency's contracted Environmental ...
New
... g., UL, IEC, FDA, CE, CSA, Energy Star). * Drive standardization of system-level specifications ... Balance internal resources, global engineering contractors, and third-party support. * Coach ...
... g., UL, IEC, FDA, CE, CSA, Energy Star). * Drive standardization of system-level specifications ... Balance internal resources, global engineering contractors, and third-party support. * Coach ...
Coordinate and oversee capital improvement projects, working with engineering teams, contractors ... FDA or other regulatory inspections * Strong technical knowledge of HVAC systems, clean room ...
Coordinate and oversee capital improvement projects, working with engineering teams, contractors ... FDA or other regulatory inspections * Strong technical knowledge of HVAC systems, clean room ...
... g., UL, IEC, FDA, CE, CSA, Energy Star). * Drive standardization of system-level specifications ... Balance internal resources, global engineering contractors, and third-party support. * Coach ...
... g., UL, IEC, FDA, CE, CSA, Energy Star). * Drive standardization of system-level specifications ... Balance internal resources, global engineering contractors, and third-party support. * Coach ...
$125K - $150K/yr
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, complaint ... Experience establishing, contracting, and managing independent repair center (IRC) networks ...
$125K - $150K/yr
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, complaint ... Experience establishing, contracting, and managing independent repair center (IRC) networks ...
Dublin, OH · On-site
$125K - $150K/yr
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, complaint ... Experience establishing, contracting, and managing independent repair center (IRC) networks ...
Dublin, OH · On-site
$125K - $150K/yr
Strong working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, complaint ... Experience establishing, contracting, and managing independent repair center (IRC) networks ...
D. Contractor Support * Support contractors performing tasks within building. * Ensure that ... Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus.
D. Contractor Support * Support contractors performing tasks within building. * Ensure that ... Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus.
D. Contractor Support * Support contractors performing tasks within building. * Ensure that ... Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus.
D. Contractor Support * Support contractors performing tasks within building. * Ensure that ... Working understanding of cGMP, GDP, and FDA requirements as they apply to maintenance a plus.
Groveport, OH · On-site
Working knowledge of OSHA, DOT, HAZMAT, FDA regulations and the willingness to become certified in ... The contractor will not discharge or in any other manner discriminate against employees or ...
Groveport, OH · On-site
Working knowledge of OSHA, DOT, HAZMAT, FDA regulations and the willingness to become certified in ... The contractor will not discharge or in any other manner discriminate against employees or ...
Columbus, OH · On-site
$107K - $146K/yr
Act as the primary liaison between CRB, clients, contractors, and vendors. * Ensure client ... Knowledge of GMP, FDA, and other regulatory requirements is a plus. Additional Information All your ...
Columbus, OH · On-site
$107K - $146K/yr
Act as the primary liaison between CRB, clients, contractors, and vendors. * Ensure client ... Knowledge of GMP, FDA, and other regulatory requirements is a plus. Additional Information All your ...
Columbus, OH · On-site
$107K - $146K/yr
Act as the primary liaison between CRB, clients, contractors, and vendors. * Ensure client ... Knowledge of GMP, FDA, and other regulatory requirements is a plus. Additional Information All your ...
Columbus, OH · On-site
$107K - $146K/yr
Act as the primary liaison between CRB, clients, contractors, and vendors. * Ensure client ... Knowledge of GMP, FDA, and other regulatory requirements is a plus. Additional Information All your ...
Ensure all automation systems meet CGMP, 21 CFR Part 11 and FDA requirements * Lead ASRS, AGVs and ... CONTRACTOR
Ensure all automation systems meet CGMP, 21 CFR Part 11 and FDA requirements * Lead ASRS, AGVs and ... CONTRACTOR
Columbus, OH · On-site
$15.50 - $21.25/hr
Oversee external contractors performing preventative and corrective maintenance, including ... Familiarity with documentation practices in regulated industries (GMP, ISO, FDA). * Previous ...
Columbus, OH · On-site
$15.50 - $21.25/hr
Oversee external contractors performing preventative and corrective maintenance, including ... Familiarity with documentation practices in regulated industries (GMP, ISO, FDA). * Previous ...
$30K - $35.3K
2% of jobs
$35.3K - $40.6K
9% of jobs
$40.6K - $46K
9% of jobs
$47.8K is the 25th percentile. Wages below this are outliers.
$46K - $51.3K
16% of jobs
$51.3K - $56.6K
12% of jobs
The median wage is $57.6K / yr.
$56.6K - $61.9K
14% of jobs
$61.9K - $67.2K
12% of jobs
$68.1K is the 75th percentile. Wages above this are outliers.
$67.2K - $72.5K
12% of jobs
$72.5K - $77.9K
8% of jobs
$77.9K - $83.2K
4% of jobs
$83.2K - $88.5K
3% of jobs
$30K
$60.8K
$88.5K

Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
Quality Assurance / Data Integrity SME
One of our clients is seeking a Quality Assurance/ Data Integrity SME to perform work predominantly onsite. This is a 6-9 month contract. Our client resides in the southwest corner of Ohio and is located in the greater Cincinnati-Wilmington-Maysville geographic area. Local candidates preferred.
Position Summary
The Quality Assurance (QA) / Data Integrity SME is responsible for ensuring compliance with GMP regulations, data integrity requirements, and company quality standards. This role supports audits, investigations, CAPAs, and regulatory inspections while serving as a subject matter expert on data integrity (paper and electronic based) and FDA 21 CFR Part 11 requirements.
Key Responsibilities
Qualifications
Required Knowledge
Preferred
Ideal Candidate: A QA professional with strong auditing experience, data integrity expertise, knowledge of FDA 21 CFR Part 11, and a proven ability to lead investigations, present CAPAs, and drive compliance improvements.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
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Pharmaceutical and medicine manufacturing
51 - 200 Employees
King of Prussia, PA, US
1962