Description

Manage raw material lot packages and ensure timely release for GMP manufacturing use. You will own the release pipeline from sample submission to final approval.

Responsibilities

• Review and release raw material lots by coordinating testing between in-house and contract laboratories.
• Author, edit, and review technical documents including deviations, change controls, SOPs, test methods, and analytical investigations.
• Execute LIMS and SAP transactions, prepare sample submission forms, and reconcile samples.
• Manage supplier qualifications by reviewing vendor documentation and material history.
• Perform data management tasks including data review, trending, and maintaining QC database records.

Required Skills

• 6 years of cGMP or equivalent experience.
• Proficiency with ANSI/ASQ Z1.4 or DIN ISO 2859 sampling standards.
• Working knowledge of CFR, USP, and ICH regulations.
• Strong technical writing skills for reports and specifications.
• Experience with lab instrumentation and Microsoft Office systems.
• Ability to manage time and prioritize tasks to meet strict release timelines.
• Demonstrated problem-detection and resolution skills.
• Physical ability to lift up to 50 pounds and perform fine finger dexterity tasks.

Preferred Skills

• Experience using SAP, Trackwise, and LIMS.

Key Skills

Education

Any Graduate