Quality Systems Specialist at Halborn

Lincoln, Nebraska, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Consumer HealthIndustries

Requirements

Bachelor’s Degree in Engineering or Science fields (or related field)
Minimum of 2 years of hands-on experience in Validation and Qualification within a GMP-regulated environment (preferably in pharmaceutical, biotech, or medical device industries)
Strong background in authoring, reviewing, and approving validation and qualification protocols and reports for facility systems, laboratory instruments, equipment, and manufacturing processes
Preferred Qualifications
Solid understanding of cGMPs, FDA regulatory expectations, and industry best practices related to validation and qualification
Proficient in applying risk-based approaches and problem-solving tools (e.g., FMEA, 5 Whys) to support validation activities and drive process improvements
Experience conducting data analysis and root cause investigations to support deviations, CAPAs, and continuous improvement initiatives
Experience in a regulated industry

Responsibilities

Assist in the validation and qualification lifecycle by reviewing and approving change controls, protocols, discrepancies, non-conformances, and final reports
Provide quality support to the Validation and Qualification team for both routine tasks and project-based work
Conduct data analysis to support investigations and process improvement initiatives, including root cause analysis
Review and support closure of engineering (PM) deviations
Participate in audit and inspection readiness activities
Maintain up-to-date knowledge of cGMPs, product types, and required training for assigned responsibilities
Perform additional duties as assigned to support departmental and site goals
EHS Responsibilities – All Associates
Understand and comply with all EHS guidelines and procedures
Promptly report unsafe conditions, injuries, illnesses, and hazardous material releases
Use appropriate personal protective equipment (PPE)
Attend required EHS training sessions
Follow all safe work practices
Quality Responsibilities – All Associates
Adhere to all quality compliance standards, including data integrity, QA, and QC requirements
Comply with Quality Management System (QMS) policies and applicable regulatory standards

Skills

cGMP

validation

qualification

change controls

non-conformances

root cause analysis

data analysis

audit readiness

inspection readiness

EHS

Halborn

Cybersecurity for blockchain and digital assets

About Halborn

Halborn specializes in cybersecurity focused on blockchain technology and digital assets. The firm provides security audits, penetration testing, and consulting services to clients in the digital finance sector, including cryptocurrency exchanges and Decentralized Finance (DeFi) companies. Their services help ensure the security of digital assets and financial infrastructure by addressing the specific security threats associated with blockchain technology. Halborn stands out from competitors due to its deep understanding of both blockchain and traditional financial security, which allows them to offer tailored solutions. The company's goal is to protect businesses from security threats, ensuring the safe operation of digital exchanges and the integrity of smart contract infrastructure.

Miami, FloridaHeadquarters

2019Year Founded

$87.5MTotal Funding

SERIES_ACompany Stage

Cybersecurity, Financial ServicesIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Company Equity

Risks

Increased targeting of Bitcoin hot wallets poses risks to Halborn's clients.

AI-powered social media bot farms could introduce new cyber threats.

Ongoing vulnerabilities in smart contracts remain a challenge for Halborn's services.

Differentiation

Halborn specializes in blockchain and digital asset cybersecurity, setting it apart.

The company offers high-level security audits and penetration testing for DeFi clients.

Halborn's expertise in both blockchain and traditional finance security is unique.

Upsides

Growing demand for blockchain security boosts Halborn's market potential.

Partnerships with Tholos and Orion Protocol enhance Halborn's Web3 security reputation.

Tokenized real-world assets present new opportunities for Halborn's security solutions.

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