Job Description

Description

We are seeking a highly skilled and detail-oriented 503B QC Chemist to join our team at FarmaKeio Outsourcing, an FDA-registered 503B outsourcing facility. The QC Chemist will be responsible for ensuring the quality, safety, and efficacy of compounded pharmaceuticals by performing a variety of testing and quality control activities. This role is critical in supporting compliance with cGMP (current Good Manufacturing Practices) and other regulatory requirements specific to the compounding industry.

Please Note: Employment at EVEXIAS/FarmaKeio is contingent upon successful completion of applicable background and/or health screenings. We kindly ask that only candidates who can confidently meet these requirements apply.

Responsibilities

Quality Control Testing:
• Perform analytical testing of raw materials, in-process samples, and finished compounded products, including but not limited to potency, sterility, endotoxin levels, and stability.
• Ensure compliance with 503B FDA guidelines, USP standards, and internal SOPs (Standard Operating Procedures).

Documentation and Record Keeping:
• Review and maintain accurate records of test results, batch records, and other required documentation to ensure traceability and compliance.
• Prepare and review other regulatory documents for finished products.

Method Validation & Development:
• Assist in the development and validation of analytical methods for product testing, ensuring they meet all regulatory requirements.
• Evaluate new technologies and methods to enhance testing capabilities and improve quality control processes.

Compliance and Audits:
• Support internal and external audits, inspections, and investigations by providing necessary documentation and test results.
• Assist in reviewing and maintaining SOPs to ensure they align with current regulatory standards.

Troubleshooting and Investigation:
• Identify and troubleshoot issues related to testing, equipment, or products.
• Investigate and report any deviations or out-of-specification (OOS) results and assist in CAPA (Corrective and Preventive Action) processes.

Equipment Maintenance and Calibration:
• Oversee the calibration and maintenance of laboratory equipment and instrumentation to ensure accurate results.
• Perform routine troubleshooting and validation of laboratory instruments.

Cross-Department Collaboration:
• Work closely with Production, Quality, and Fulfillment teams to ensure alignment of product quality standards and testing requirements.

Safety and Cleanliness:
• Adhere to safety guidelines and maintain a clean and organized lab environment.
• Ensure compliance with safety standards for the handling of chemicals and hazardous materials.

Qualifications

Education:
• Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field.
• Master's degree or higher in a relevant field is a plus.

Experience:
• Minimum of 2-3 years of experience in a Quality Control or Analytical Chemistry role, preferably within a 503B pharmacy, pharmaceutical manufacturing, or related industry.
• Familiarity with USP, FDA 503B guidelines, and cGMP regulations.
• Experience with laboratory instrumentation.

Skills and Abilities:
• Strong analytical and problem-solving skills.
• Excellent attention to detail and accuracy in documentation.
• Proficient in using laboratory software and instrumentation.
• Strong communication skills (both written and verbal) and the ability to work effectively in a team environment.

Job Tags

Full time,

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