13 quality systems specialist jobs at 7 companies in Dover, NH

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Quality Systems Specialist - CAPA
Manchester, New Hampshire, United States
OnsiteFull Time
Merrimack Manufacturing
Merrimack Manufacturing: Private U.S. medical-device contract manufacturer producing lifesaving devices for designers and their patients.
2+ YOEAssociate or bachelor's degree preferred; 2–5 years in quality systems, quality assurance, or a regulated industry. Requires CAPA experience, ISO 13485 and FDA QSR knowledge, root cause analysis, and Microsoft Office proficiency.
Microsoft Office, electronic QMS systems, 5-Why, Fishbone, fault tree analysis
2mo
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Lead Quality Systems Specialist
Lawrence, Massachusetts, United States
$117k-$196k/yr OnsiteFull Time
Fresenius Medical Care North America
Fresenius Medical Care North America: Private U.S. renal healthcare providing dialysis, kidney care, vascular services, pharmaceuticals, and dialysis equipment.
6+ YOEBachelor's degree, 6+ years related experience, deep knowledge of quality systems, recalls/corrections & removals, regulatory requirements (US, Health Canada, Mexico), Microsoft Access/Outlook/ERP skills, audit and training experience.
Microsoft Access, Microsoft Outlook, ERP software, Microsoft Office
2mo
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Quality Systems and Training Support Specialist
Amesbury, Massachusetts, United States
$57k-$98k/yr OnsiteFull Time
Hexcel
HexcelNYSE: HXL: Global leader in advanced lightweight composite technology.
HS/GED required; proficiency with Microsoft Office; experience supporting CMMS, LMS, DMS, NCM/CAPA and calibration databases; records management, report generation, strong written and verbal communication; U.S. citizenship required.
CMMS, LMS, DMS, NCM, CAPA, Microsoft Word, Microsoft Outlook, Microsoft Excel, Microsoft PowerPoint
3mo
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Computer Systems Validation Specialist III
Portsmouth, New Hampshire, United States
OnsiteFull Time
Lonza
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
3+ YOEBachelor's in computer science or engineering; 3+ years CSV experience; 3+ years in a cGMP facility; experience with 21 CFR Part 11 and ISPE GAMP; background in biotech/pharma/medical devices; ability to work on-site in Portsmouth, NH.
QMS software, Documentation tools
1w
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QA Specialist II - Ops Floor Support
Bedford, New Hampshire, United States
OnsiteFull Time
PCI Pharma Services
PCI Pharma Services: Global contract development and manufacturing organization for biopharma.
3+ YOEBachelor's degree in a relevant scientific field and 3+ years of relevant GMP industry experience, including 1+ year in Quality, or equivalent experience. Requires investigations, technical writing, and quality systems experience.
FMEA, HACCP, PHA, ICH Q9
2w
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QA Compliance Specialist - LSA
Portsmouth, New Hampshire, United States
OnsiteFull Time
Lonza
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
3+ YOERequires 3+ years in quality assurance, compliance, or quality systems in a GMP-regulated life sciences environment, with cGMP, FDA, ICH, quality events, audits, and eQMS experience.
TrackWise, Veeva, MasterControl
2w
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Compliance Specialist
Bedford, New Hampshire, United States
OnsiteFull Time
PCI Pharma Services
PCI Pharma Services: Global contract development and manufacturing organization for biopharma.
2+ YOERequires 2+ years in GMP, ISO, or FDA-regulated environments, quality-system technical writing, cGMP investigations, root-cause and risk analysis; science or engineering bachelor's preferred.
GMP, ISO, FDA, CAPA, SOP
1mo
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QA Specialist II - Operations
Portsmouth, New Hampshire, United States
OnsiteFull Time
Lonza
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
Experience with cGMP, good documentation practices, familiarity with manufacturing and quality systems, ability to identify compliance issues and support inspection readiness.
SAP, LIMS, TrackWise, Syncade
3mo
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LSA QA Sr. Compliance Specialist
Portsmouth, New Hampshire, United States
OnsiteFull Time
Lonza
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
5+ YOEMinimum 5+ years in Quality Assurance/Quality Systems in GMP-regulated pharma/biotech; strong knowledge of cGMP; experience with deviations, CAPAs, change controls, and audits; excellent communication and cross-functional collaboration; experience with eQMS (TrackWise, Veeva, MasterControl) preferred.
TrackWise, Veeva, MasterControl, Quality Management System
2w
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Manufacturing Operation and Compliance Specialist
Billerica, Massachusetts, United States
OnsiteFull Time
Sun Pharmaceutical Industries
Sun Pharmaceutical IndustriesNSE: SUNPHARMA: Global specialty generic pharmaceutical headquartered in India.
5+ YOERequires a high school diploma, 5+ years supporting manufacturing or quality departments, and knowledge of GMP, quality systems, CAPAs, change controls, deviations, documentation, and compliance reporting.
Track Wise, EDMS, MasterControl
3w
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QA Specialist V - QA Inspection Audit Management
Portsmouth, New Hampshire, United States
OnsiteFull Time
Lonza
LonzaSIX Swiss Exchange: LONN: A global partner to the pharmaceutical and biotech industries.
8+ YOEBachelor's in life sciences,8+ years QA in GMP-regulated environment,strong GMP (FDA/EMA/ICH) knowledge,audit and inspection leadership,CAPA and quality systems experience,TrackWise familiarity,data integrity understanding;CQA preferred.
TrackWise
3w
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Shipping Receiving Specialist II
Nashua, New Hampshire, United States
OnsiteFull Time
Infor
Infor: Global provider of industry-specific enterprise cloud software.
Execute outbound logistics tasks including picking, packing, shipping documentation, system transactions in Infor WMS/ERP, carrier coordination, quality checks, and inventory support.
Infor WMS/ERP
2mo
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Regulatory Affairs Specialist I
Minnetonka or Portsmouth
HybridFull Time
Laborie Medical Technologies
Laborie Medical Technologies: Privately owned medical-device manufacturer serving clinicians and hospitals with diagnostic/therapeutic products in urology, gastroenterology, and obstetrics.
1+ YOEBachelor's degree in science/engineering,1-3 years regulatory affairs experience in medical device industry,experience with international registrations and quality system regulations,strong communication and organization skills.