Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, Life Sciences, CDMOIndustries
Requirements
- Bachelor’s degree in Scientific field + 5 years of experience working in a related laboratory environment OR Master’s +2 years OR Ph.D. + 1 year
- Knowledge of Quality Management Systems (ISO 13485 or cGMP) and Good Documentation Practices
- Experience in writing complex technical SOPs for clarity and ease of use
Responsibilities
- Independently perform complex QC assays for biological macromolecules (Concentration, Purity, Activity, Residual, Compendial) according to established standard operating procedures under minimal direction from the QC Supervisor
- Represent Aldevron in internal and external client meetings as a Subject Matter Expert in one or more analytical technical areas
- Lead investigations for Out of Specification / Out of Trend results using hypothesis tests and root cause analysis techniques; applies sustainable corrective actions
- Train and mentor Quality Control Scientists and Analysts
- Write and revise Standard Operating Procedures, Forms, Protocols, and Reports
Skills
QC assays
biological macromolecules
Concentration analysis
Purity analysis
Activity assays
Residual analysis
Compendial testing
method validation
SOP
analytical techniques
Danaher Corporation
Water quality, diagnostics, and identification solutions
About Danaher Corporation
Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.
Washington, District of ColumbiaHeadquarters
1969Year Founded
IPOCompany Stage
Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries
10,001+Employees
Risks
Increased competition from Roche and Abbott in AI-driven diagnostics.
Potential regulatory challenges in the EU for water quality sector.
Supply chain vulnerabilities affecting precision instruments sourcing.
Differentiation
Danaher's Danaher Business System drives continuous improvement and superior financial performance.
The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.
Danaher's advanced purification technologies meet increasing demands for sustainable water management.
Upsides
Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.
Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.
Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.
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