Lead quality management at the Warren, MI laboratory, implementing ISO/IEC 17025 compliant QMS, driving continuous improvement, and maintaining accreditations.
Responsibilities
Conduct maintenance and scope extension of all accreditations
Implement and maintain the QMS
Effectively manage day-to-day implementation of the QMS
Responsible for the quality review, disposition, and release of commercial products marketed in the United States.
Compensation
The target base salary range for this role is $84,800-$106,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors. In addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.
Responsibilities
Perform quality review and approval of commercial product release packages for Rx, OTC, and Cosmetics products.
Ensure all release documentation is complete, accurate, and compliant with applicable regulatory requirements, internal procedures, and quality standards.
Review manufacturing, packaging, testing, and disposition records provided by contract manufacturing organizations and contract laboratories.
Evaluate deviations, investigations, change controls, CAPAs, and other quality events for potential impact on product disposition decisions.
Conduct risk-based assessments to support product release decisions and ensure products meet established quality requirements.
Technical authority for nondestructive testing at Hadrian, owning procedures, qualification, audit readiness, and automation integration.
Compensation
For this role, the target salary range is $150,000- $210,000 (actual range may vary based on experience).
Responsibilities
Serve as the Level III technical authority for NDT, owning the development, review, approval, and control of procedures, technique sheets, and the written practice.
Own program governance, including revision control, personnel qualification and certification, calibration, and equipment traceability.
Lead audit readiness and represent NDT in internal, customer, and third-party audits.
Design and run POD and capability studies, and build the technical case for new and non-traditional inspection techniques.
Partner with automation and software teams to specify, validate, and deploy automated inspection, while mentoring Level I and II personnel.
Lead and manage the GxP Quality Audit Program, conducting internal, supplier, and partner audits, driving continuous improvement and inspection readiness.
Compensation
Salary Range: $140,000 - $150,000
Responsibilities
Develop and maintain audit strategy and schedule
Lead risk-based audits and manage audit teams
Prepare and review audit reports
Coordinate supplier and partner audits
Track audit findings and CAPA follow-up
Requirements
Bachelor’s degree in Life Sciences, Biotechnology, Engineering, Chemistry, Quality, Pharmacy, or another relevant scientific or technical discipline
Lead senior quality leadership for design, integration, and execution of complex remediation programs at Round Lake Drug Delivery.
Compensation
The estimated base salary for this position is $112,000 - $154,000 annually.
Responsibilities
Lead development, integration, and execution of site remediation strategies arising from regulatory inspections, Warning Letters, OAI classifications, health-authority commitments, audits, quality-system assessments, and significant recurring quality signals.
Translate commitments and identified gaps into clearly defined workstreams, accountable owners, milestones, dependencies, deliverables, interim controls, effectiveness measures, and objective closure evidence.
Establish and maintain a risk-based remediation master plan and governance cadence that provides clear visibility to progress, overdue actions, critical-path constraints, resource needs, decision requirements, and emerging risks.
Provide independent Quality oversight and constructive challenge to ensure remediation plans are technically sound, scientifically justified, regulatorily defensible, feasible, and aligned with commitments made to health authorities and internal governance bodies.
Drive cross-functional execution across Quality, Manufacturing, Engineering, Maintenance, Facilities, Laboratories, Supply Chain, Regulatory Affairs, IT, Training, and Operational Excellence to remove barriers and maintain alignment.
Typical starting pay for this position ranges from $28.00–$35.00 per hour, based on relevant experience, education, skills, and internal equity. The fully established pay range for the position extends up to $42.00 per hour.
Responsibilities
Review and approve quality and product-release records
Investigate quality issues and root causes
Initiate and support Corrective and Preventive Actions (CAPAs)
Review quality data and metrics to identify trends
Track mitigation efforts to reduce risks
Requirements
Associate's degree in Technical, Scientific, Quality, or related field
Nice to have: prior experience in medical device, biotechnology, or biopharma industry
Nice to have: prior experience in ISO or FDA-certified manufacturing environment
Support BioTechnique’s Quality Control operations by executing microbiological and environmental monitoring activities in a sterile manufacturing setting.
Responsibilities
Execute microbiological and environmental monitoring of product samples, utilities, surfaces, air, and personnel according to SOPs and compendial standards
Conduct disinfectant efficacy testing (DET) and related microbiological assays
Prepare and maintain media, sampling kits, and test solutions per SOPs and compendial requirements
Operate biological safety cabinets and laboratory instrumentation while following aseptic techniques
Perform routine cleaning and sanitization of laboratory spaces and support equipment maintenance and calibration
Responsible for administering, maintaining, and continuously improving Apnimed's electronic Quality Management System (eQMS) and associated quality processes, ensuring inspection readiness and supporting regulatory compliance.
Compensation
The expected annual base salary range for this role is $170,000.00 to $190,000.00.
Responsibilities
Serve as subject matter expert and administrator for the electronic Quality Management System (eQMS), evaluating proposed system changes and coordinating testing, validation, and deployment activities.
Support the integration of new business processes, departments, and vendors into the Quality Management System, and oversee onboarding, knowledge transfer, and competency requirements for new eQMS administrators.
Maintain system documentation, including procedures, work instructions, validation documentation, and configuration records.
Administer the training program: confirm assignments and curricula reflect quality system responsibilities, manage role-based eQMS training and user support, and maintain a centralized library of user guidance, job aids, and FAQs.
Provide oversight and support for core quality processes, including document control, deviations, CAPAs, change controls, investigations, supplier quality records, and training management.
Requirements
Bachelor's degree or equivalent in a scientific, technical, engineering, quality, or related discipline.
Medical Laboratory Scientist Quality Lead, HMC Transfusion Services Lab
Serve as a technical resource for complex serologic investigations, transfusion-related patient safety events, regulatory compliance activities, and process improvement initiatives within the Transfusion Services Laboratory.
Compensation
Pay Range Minimum: $44.25 hourly
Pay Range Maximum: $65.23 hourly
Responsibilities
Serve as the lead MLS resource for transfusion service operations, technical quality, and blood bank patient safety practices across all campuses
Lead technical investigation and resolution of transfusion-related deviations, non-conforming events, and patient safety concerns
Coordinate interdisciplinary review activities with laboratory staff, supervisors, medical directors, nursing, anesthesia, and clinical teams regarding transfusion-related quality and safety issues
Provide lead-level coordination and leadership of daily transfusion quality operations and workflows
Review quality data trends and investigation outcomes to identify systemic risks and operational improvement opportunities
Requirements
Accredited bachelor’s degree in medical laboratory science OR equivalent education/experience
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