Co-op, Bio Quality Assurance, Risk Management

Role Summary

This is a 6-month student Co-op in Bio Quality Assurance at Biogen's RTP facility. The role focuses on Quality Risk Management and Inspection Readiness within a biopharmaceutical setting. You will engage in tactical and operational QA activities to uphold high quality standards, with emphasis on risk management processes and ensuring inspection readiness. Standard hours are 8:00 am–4:30 pm, Monday through Friday.

Responsibilities

• Collaborate with QA personnel to prioritize, review, and update current risk assessments for the Biogen RTP Bio site.
• Gain insight into the quality operations activities of a biopharmaceutical operation.
• Support the evaluation of risk assessments to ensure appropriate Failure Mode and Effects Analysis have been conducted.
• Determine the necessity for periodic re-evaluations of risk assessments.
• Evaluate critical aspects for inspection readiness to ensure they are supported by up-to-date risk assessments.
• Assist in updating work procedures that integrate risk assessment findings.
• Participate in team meetings and contribute to discussions on quality assurance strategies.

Qualifications

• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work effectively both independently and as part of a team.
• Prior experience or internship in a quality assurance or biopharmaceutical environment.
• Familiarity with Risk Management principles and practices.
• Legal authorization to work in the U.S.
• At least 18 years of age prior to the scheduled start date.
• Currently enrolled in an accredited community college, college, university or skills program/apprenticeship.

Education

• BA/BS degree in progress in a related field.