Duration: 3 Months (Possibility for Extension or Conversion for Full-Time)
POSITION SUMMARY
The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA On-The-Floor (OTF) oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products.
KEY RESPONSIBILITIES
Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product - 75% of day is spent on the floor.
Performs QA on the Floor activities supporting client projects, 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
Perform Acceptable Quality Limit (AQL) visual inspection of drug product
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 SMP's
Compile deviations as required when observed on the floor, and move to completion within the required time frame
Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product - 75% of day is spent on the floor.
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 and continuous improvement initiatives
Participate in site and corporate quality and process improvement initiatives.
Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.
Actively participates in training activities, managing their individual training plan.
Other duties as assigned.
POSITION 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.
OR
Bachelor's degree in a Scientific, Engineering or Biotech field with 2 - 4 years' experience in Quality Assurance/Quality Control/Maufacutring 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.
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.
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