Associate III, Quality Control Raw Materials

Role Summary

Associate III, Quality Control Raw Materials at Biogen RTP is a full-time, on-site role (M–F, 8:00 AM–5:00 PM). The position supports QC Raw Materials objectives by sampling, inspecting, and testing raw materials in compliance with cGMP documentation standards. Expertise in Gas Chromatography (GC) and wet chemistry is essential for compendial testing and data entry into electronic laboratory information management and inventory systems.

Responsibilities

• Perform raw material sampling, inspections, and release testing.
• Conduct utility monitor samples to ensure quality standards.
• Provide technical review of data and documentation for QC Raw Materials.
• Support investigations and QC operations in alignment with business and manufacturing schedules.
• Assist in process validation initiatives to maintain compliance.
• Maintain effective laboratory systems to ensure the integrity of results.
• Collaborate with various teams to support laboratory compliance and personal development.
• Enter data into electronic laboratory information management and inventory systems.
• Manage retention samples and training to sustain 100% compliance.

Qualifications

• Bachelor's degree in science or related field (Required).
• Minimum 2 years of relevant experience in QC within a GMP pharma or biotech environment (Required).
• Experience with Gas Chromatography (GC) and wet chemistry per compendia (Required).
• Ability to move 50 lbs with the assistance of equipment as needed (Required).
• Demonstrated technical ability in fundamental laboratory techniques and analytical methodology (Required).
• Strong organizational skills with the ability to multitask and coordinate multiple activities (Required).
• Excellent communication skills, both written and verbal (Required).
• Ability to interpret data and draw conclusions (Required).

Education

• Bachelor's degree in science or related field

Skills

• Gas Chromatography (GC) and wet chemistry proficiency
• Laboratory data interpretation and documentation
• Electronic laboratory information management systems data entry
• Quality assurance and cGMP compliance
• Cross-functional collaboration and effective communication