Quality Control Analyst

Terms: 6 month contract to hire (possibly DH for the right candidate/experience

Salary Range: $34-$38/hr DOE

Schedule: Monday-Friday 9a-5p

Top Targets:

• Proven experience with HPLC, GMP, GLP, and GDP is required.
• Preferred experience with radioactive materials, gamma spectroscopy, sterility testing, aseptic technique, and raw materials testing.

About Us:

Our client is a leader in the pharmaceutical industry, dedicated to delivering high-quality products that meet the highest standards of safety and efficacy. We are committed to innovation and excellence, and we are seeking a dedicated QC Analyst to join our dynamic team.

Position Overview:

The QC Analyst will be responsible for performing quality control testing and analysis of raw materials, in-process samples, and finished products. This role requires expertise in high-performance liquid chromatography (HPLC), knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP). The ideal candidate will also have experience with radioactive materials, gamma spectroscopy, sterility testing, aseptic technique, and raw materials testing.

Key Responsibilities:

Testing and Analysis:

• Perform analytical testing using HPLC and other laboratory techniques.
• Conduct testing of raw materials, in-process samples, and finished products.
• Perform gamma spectroscopy and analyze results as needed.
• Execute sterility testing and ensure compliance with established procedures.

Documentation and Compliance:

• Maintain accurate and detailed records of all testing and analysis activities in compliance with GMP, GLP, and GDP.
• Review and compile test data, and prepare comprehensive reports.
• Ensure that all laboratory activities are conducted in accordance with safety regulations and company policies.

Quality Assurance:

• Assist in the development and validation of test methods and procedures.
• Identify and investigate deviations or out-of-specification results, and contribute to root cause analysis and corrective actions.
• Support internal and external audits by providing necessary documentation and information.

Materials Handling:

• Safely handle and dispose of radioactive materials according to established protocols.
• Utilize aseptic techniques to maintain the integrity of samples and prevent contamination.

Collaboration and Improvement:

• Work closely with other QC team members and departments to ensure seamless operations and adherence to quality standards.
• Participate in continuous improvement initiatives to enhance testing processes and efficiency.

Qualifications:

• Education: Bachelor’s degree in Chemistry, Biochemistry, Life Sciences, or a related field.
• Experience: Minimum of 2 years of experience in:
• Proven experience with HPLC, GMP, GLP, and GDP is required.
• Preferred experience with radioactive materials, gamma spectroscopy, sterility testing, aseptic technique, and raw materials testing.

Skills and Competencies:

• Strong analytical skills and attention to detail.
• Proficiency in using laboratory equipment and software.
• Excellent documentation and organizational skills.
• Ability to work independently and as part of a team.
• Strong problem-solving skills and a proactive approach to identifying and addressing issues.

Physical Requirements:

• Ability to lift up to (weight) pounds.
• Ability to stand for extended periods and perform repetitive tasks.