Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

The Investigation Reviewer to support our pharmaceutical manufacturing operations. This role is responsible for reviewing and assessing investigations related to solid dosage forms and parenteral products, ensuring compliance with regulatory standards and internal procedures.

Review and approve manufacturing investigations for solid and parenteral processes, including deviations, batch failures, and out-of-specification results.
Collaborate with cross-functional teams (Production, Quality Control, Engineering, Regulatory Affairs) to gather relevant data and support root cause analysis.
Evaluate corrective and preventive actions (CAPAs) for effectiveness and alignment with quality standards.
Maintain documentation integrity and ensure timely closure of investigations.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, or related field.

• Minimum 5 years of experience in pharmaceutical manufacturing, with direct involvement in solid and parenteral dosage forms.

• Strong understanding of GMP, FDA, and other regulatory guidelines.

• Experience with investigation systems.

• Excellent analytical, writing, and communication skills.

Additional Information

All your information will be kept confidential according to EEO guidelines.