Analytical Quality Assurance Specialist
2 weeks ago
Position Overview: This role involves conducting analytical evaluations and providing support within the HPLC/Capillary Electrophoresis (CE) division of Clinical Quality Assurance.
This is a 1-year renewable contract position requiring onsite attendance during standard business hours.
Key Responsibilities:
- Engage in various activities within Quality Control, including analytical evaluations, sample and data oversight, and equipment upkeep.
- Execute standard laboratory procedures such as sample evaluations and preparation of standards and solutions.
- Document, compile, analyze, review, and input laboratory data accurately.
- Communicate findings effectively, operate specialized equipment, and draft/revise documents like Analytical Methods, SOPs, and technical reports.
- Assist in the integration of new methodologies and techniques into the laboratory.
- Conduct basic troubleshooting of assays and instruments.
- Identify, suggest, and implement enhancements related to routine tasks.
- Adhere to safety protocols and basic cGMP regulations.
- Demonstrate flexibility in work schedules as necessary.
- Be available for on-call duties as required.
Essential Qualifications:
- Bachelor's degree with 2 years of experience in Quality Control, Quality Assurance, or a related field; OR an Associate degree with 6 years of relevant experience; OR a High school diploma/GED with 8 years of related experience.
Critical Skills Required:
- Proficiency in HPLC and/or Capillary Electrophoresis methodologies.
- Strong adherence to regulatory standards, documented procedures, and safety protocols.
- Flexibility and adaptability to shifting priorities and requirements.
Desirable Qualifications:
- Experience with HPLC and/or Capillary Electrophoresis techniques.
- Ability to comply with regulatory standards and procedural documentation.
- Capability to assess documentation/data in line with company and regulatory standards.
- Strong organizational skills to manage multiple priorities and meet deadlines.
- Excellent written and verbal communication abilities.
- Attention to detail is essential.
- Flexibility and adaptability to changing demands and priorities.
- Understanding of regulatory standards, safety protocols, and compliance factors.
- Ability to recognize when to escalate issues appropriately.
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