QA Specialist-Medical Devices

Job Title: QA Specialist-Medical Devices

Location: Baltimore,MD

Start Date: October 21, 2024

Duration: 3 months (with the possibility of extension)

Interview Process: MS Teams interview and a follow-up phone or MS Teams interview with the client.

Position Summary

The QA Specialist is responsible for providing Quality Assurance support for GMP manufacturing of master/working cell banks, biological bulk drug substances, and finished drug products intended for human consumption. This role involves on-the-floor oversight of manufacturing operations, ensuring compliance with regulatory and industry standards, and promoting quality improvements and efficiency in phase-appropriate GMP manufacturing of biological products.

Key Responsibilities

• Quality Floor Oversight:
• Provide dedicated QA oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substances, and final drug products (75% of the day spent on the floor).
• On-the-Floor QA Activities:
• Support client projects through room release, observation of critical processes, real-time batch documentation review, cleaning documentation, and logbook oversight.
• Resolve issues that arise during manufacturing.
• Collaboration:
• Partner with Manufacturing and other support teams to ensure compliance and efficiency.
• Visual Inspection:
• Perform Acceptable Quality Limit (AQL) visual inspections of drug products.
• Documentation Review:
• Review and approve batch documents for media and buffer preparation solutions.
• Generate or revise GMP documentation, including Standard Operating Procedures (SOPs) and Master Batch Records.
• Deviation Management:
• Compile and manage deviations observed on the floor, ensuring timely resolution.
• Audits:
• Conduct audits of manufacturing and support areas, reviewing in-process batch records for adherence to internal procedures and Good Documentation Practices.
• Quality Decision-Making:
• Make informed quality decisions with limited oversight and identify continuous improvement initiatives.
• Training Participation:
• Actively engage in training activities and manage individual training plans.
• Other Duties:
• Perform additional responsibilities as assigned.
  

Position Requirements

• Education:
• Master's degree in a Scientific, Engineering, or Biotech field with 0-2 years of experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry;
• OR
• Bachelor’s degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
• Regulatory Knowledge:
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600, ICH Guidelines, and EU GMPs.
• Process Knowledge:
• Knowledge or exposure to biological manufacturing processes, including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
• Analytical Skills:
• Strong analytical, troubleshooting, and decision-making skills, with the ability to apply scientific and regulatory principles to operational and quality tasks.
• Technical Skills:
• Familiarity with electronic systems and report generation using Microsoft products; experience with LIMS, MasterControl, and Trackwise preferred.
• Adaptability:
• Ability to quickly learn new manufacturing processes and support new clients.
• Teamwork and Independence:
• Able to work effectively in both team settings and independently under supervision.
• Fast-Paced Environment:
• Demonstrated ability to produce results in a fast-paced environment and meet client deadlines
  

If you are interested to apply! Please get in touch with me at ahmed@intellectt.com or 1-732-653-9472