QC Materials Inspector I – GMP Sampling & QA

Bora Pharmaceuticals; Rockville (MD); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Health coverage

401k matching

Paid time off

Professional development

Wellness programs

Employee Assistance Program

Job summary

Bora Pharmaceuticals in Rockville, MD is seeking a Materials Verification Technician to inspect, sample and verify incoming raw materials for cGMP manufacturing. You will coordinate with Materials Management to ship samples for testing at contract labs and assist in maintaining documentation and data in SAP/LIMS.

Primary duties include following SOPs, supporting stability sampling, and ensuring equipment and room readiness.

Qualifications

• High School Diploma with 2+ years directly related experience.
• Associate's Degree with 1+ year directly related experience.
• Bachelor's Degree in a scientific discipline.

Responsibilities

• Performs inspection, sampling and verification of incoming raw materials according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents, per schedule and within established turn-around times.
• Collaborates with Materials Management to prepare shipments of raw material samples for testing performed by contract laboratories.
• Follows established procedures and performs tasks in accordance with cGMP requirements.
• Assists in the development and revision of raw material specifications and testing plans.
• Performs physical inspections of stored materials.
• Sets down and pulls samples per the stability program.
• Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP. Compiles and reviews data per cGMP. Ensures data storage and archiving are performed per established procedures.
• Ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state and raises any concerns about equipment to supervisor for resolution.
• Maintains the sampling room at constant state of compliance and inspection readiness at all times and ensures that sampling room inventory is stocked with required cleaning solutions, sample containers, labels, etc., and coordinates with appropriate departments when there are issues/concerns.
• Reports discrepancies and nonconforming materials to management and supports subsequent investigations and other Quality event records (e.g., Deviations and CAPAs).
• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.
• Performs other duties as assigned.

Skills

Aseptic technique

Cell culture

GMP knowledge

Quality Control

GMP testing

Education

High School Diploma

Associate's Degree

Bachelor's Degree in a scientific discipline

Job description

Bora Pharmaceuticals in Rockville, MD is seeking a Materials Verification Technician to inspect, sample and verify incoming raw materials for cGMP manufacturing. You will coordinate with Materials Management to ship samples for testing at contract labs and assist in maintaining documentation and data in SAP/LIMS.

Primary duties include following SOPs, supporting stability sampling, and ensuring equipment and room readiness.