Senior Automation Engineer will lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Responsibilities
Lead internal team members, suppliers, OEMs, system integrators, Digital/IT partners, automation-system owners, and cross-functional stakeholders to deliver OT infrastructure, industrial networking, integration, historian, virtualization, cybersecurity, and lifecycle initiatives in a cGMP manufacturing environment.
Own vision requirements and inspection specifications across filling, AVI, device assembly, and packaging.
Define inspection scope and measurable acceptance criteria with Quality and equipment specialists, resolving supplier and integration gaps.
Specify, configure, and troubleshoot cameras, lenses, illumination, exposure, triggering, and image geometry.
Establish stable image acquisition across product formats, equipment speeds, and expected variation in materials and presentation.
Senior technical leader responsible for investigation oversight and analytical problem‑solving support across the Quality Control organization.
Compensation
$162,000—$175,000 USD
Responsibilities
Oversee QC OOS, OOT, deviations, atypical results, invalid assays, and laboratory investigations across Chemistry, Microbiology, and Raw Materials
Lead or facilitate complex, high‑impact, recurring, or cross‑functional investigations
Ensure investigations include clear problem statements, hypotheses, scientifically justified testing, defensible root causes, product‑impact assessments, and CAPAs where appropriate
Challenge root‑cause conclusions not adequately supported by data
Facilitate root‑cause analysis using 5‑Why, fishbone/Ishikawa, fault‑tree, and FMEA/risk‑based tools
Requirements
Bachelor's degree in Chemistry, Biochemistry, Biology, Microbiology, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline
Nice to have: Master's degree or advanced scientific degree
Support QC testing for in-process, final product, and stability samples, including data review/verification, method transfer, documentation, deviations, investigations, and continuous improvement efforts.
Compensation
Summit West - NJ - US: $34.82 - $42.19per hour
Responsibilities
Perform routine testing of in-process, final product, and stability samples
Perform testing for method transfer/validation/verification
Perform data verification, data review and review of GMP documentation for general methods
May perform document revision, project, CAPA and deviation/ investigation related tasks and/or continuous improvement efforts
Senior Associate Plant QA responsible for providing QA guidance, batch record review, and support for production operations at AOH.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 82,081.95USD -111,052.05 USD
Responsibilities
Provide daily guidance and support to Production staff regarding compliance with SOPs and Work Instructions
Ensure regular presence in device assembly and packaging areas to monitor GMP operations and quality systems
Act as a first point of contact for production queries during packaging and labeling operations
Lead, mentor, and coach Operations and support personnel on quality matters
Review and approve batch production records and other GMP documentation
Requirements
High school/GED + 4 years of Quality and/or GMP Manufacturing experience
Associate’s + 2 years of Quality and/or GMP Manufacturing experience
Bachelor’s + 6 months of Quality and/or GMP Manufacturing experience
Master's
Nice to have: Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Provide quality engineering support for neurovascular products throughout product development, design changes, technical transfer, manufacturing transfer and sustaining activities.
Compensation
$45/hr to $52/hr on W2
Responsibilities
Provide quality engineering support for Cerenovus neurovascular products throughout product development, design changes, technical transfer (tech transfer), manufacturing transfer and sustaining activities
Prepare, develop, review, maintain and approve Quality Plans and Product Development Process deliverables, including protocols, reports, specifications and engineering documentation
Review and approve R&D/Engineering verification and validation protocols and reports
Develop and maintain risk management records, including DFMEA and PFMEA, in collaboration with subject matter experts
Support and provide quality guidance for process validation and equipment qualification activities, including IQ, OQ and PQ
The Quality System Specialist supports the effective operation, maintenance, and continuous improvement of Meridian Bioscience’s Quality Management System (QMS) within a regulated medical device/IVD environment.
Compensation
Compensation Range: $69,800 to $111,800
Responsibilities
Support the maintenance and effective implementation of Quality Management System processes, ensuring procedures and records remain current, controlled, and compliant with applicable requirements, including 21 CFR Part 820, ISO 13485, cGMP, and company procedures.
Execute and monitor document control and records management activities, including controlled documents, changes, periodic reviews, archival, and electronic QMS workflows.
Support inspection and audit readiness by preparing documentation, retrieving objective evidence, participating in internal, supplier, customer, and regulatory audits, and supporting timely responses to findings.
Support CAPA, nonconformance, deviation, complaint trending, and other quality system investigations as assigned, including documentation, root cause analysis, effectiveness checks, and closure activities.
Identify quality system improvement opportunities using metrics, trend analysis, risk-based thinking, and feedback from internal customers.
Requirements
Bachelor’s degree in Quality, Engineering, Life Sciences, Business, or a related field, or equivalent combination of education and relevant experience.
The QA Operations Specialist, Validation, is responsible for providing Quality Assurance oversight, review, and approval of qualification and validation activities associated with equipment, facilities, utilities, systems, and manufacturing processes at the Cumberland, RI site.
Responsibilities
Perform independent QA review and approval of qualification and validation documentation, including protocols, reports, discrepancies, requirements specifications, risk assessments, and supporting records.
Ensure validation documentation complies with NT’s approved validation procedures and in accordance with CGMP and GDP.
Provide QA oversight of qualification and validation lifecycle activities, including IQ/OQ/PQ, and assess changes or discrepancies that may impact the validated state.
Collaborate with Validation, Mfg, QC, and other functional areas to support validation activities.
Provide technical mentorship and guidance to Neurotech personnel on qualification and validation documentation.
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