Quality Assurance Specialist

4 weeks ago

Baltimore, Maryland, United States Medvacon Life Sciences Full time
Job Title: Specialist, QA OTF

Medvacon Life Sciences is seeking a highly skilled Specialist, QA OTF to provide Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance, and finished drug product.

Key Responsibilities:
  • Provide dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance, and/or final drug product.
  • Perform QA on the Floor activities, including room release, observing critical processes, reviewing batch documentation in real-time, cleaning documentation, logbooks, and resolving issues that occur during manufacturing.
  • Partner with Manufacturing and other support teams to ensure compliance with applicable regulatory and industry standards.
  • Review and approve batch documents for media and buffer prep solutions.
  • Generate or revise GMP documentation, such as Standard Operating Procedures, Master Batch Record review, and SMPs.
  • Compile deviations as required when observed on the floor and move to completion within the required time frame.
  • Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.
  • Make solid quality decisions with limited oversight.
  • Identify and implement continuous improvement initiatives.
  • Participate in site and corporate quality and process improvement initiatives.
  • Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
  • Actively participate in training activities, managing their individual training plan.
Requirements:
  • Masters' degree in a Scientific, Engineering, or Biotech field with 0-2 years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
  • Bachelor's degree in a Scientific, Engineering, or Biotech field with 2-4 years' experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.
  • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs.
  • Knowledgeable and/or exposure to biological manufacturing processes, including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.
  • Ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks.
  • Familiarity with electronic systems, including developing and producing reports using Microsoft products.
  • Creative individual with excellent analytical, trouble-shooting, and decision-making skills.
  • Ability to quickly learn new and novel manufacturing processes supporting new clients.
  • Able to work in a team setting and independently, under supervision.
  • Requires the ability to produce results in a fast-paced environment to meet client deadlines.

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