Position: Manufacturing Quality Associate
The Manufacturing Quality Associate is responsible for supporting the design and implementation of robust Quality Systems for a new viral gene therapy manufacturing site and quality on the manufacturing floor.
This successful candidate will be responsible for quality operations on the manufacturing floor and working in collaboration with Manufacturing Operations to review and advise on written procedures including but not limited to: monitor and control the manufacturing environment, plant hygiene, process validation, people/process/waste flow patterns, aseptic certification, nonconformance review/disposition, and monitoring compliance with all requirements of good manufacturing practice.
The Manufacturing Quality Associate will be responsible for quality related business systems such as non-conformance/CAPA, by contributing and reviewing for approval and assisting with the implementation and supporting on-going continuous improvements. The Manufacturing Quality Associate will provide critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a good knowledge of and application of the CFR's and cGMP's .
- Assist with and provide information to close non-conformances and CAPAs
- Willing to work off-shift hours
- Complete on the floor quality audits and sampling during the manufacturing processes; knowledge of AQLs and visual inspection preferred
- Good understanding of batch record execution, GMP and GDP
- Work effectively with operators on the floor and make on the spot, risk based decisions; escalate issues to management as necessary
- Assist in developing and delivering robust overall quality systems resulting in a fully compliant facility with respect to procedures and processes
- Contribute to the key plant metrics for the Quality Management Review meeting (QMR) to ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics; reporting to management all necessary information from plant floor
- Provide support on quality input on the translation of commercial product requirements into a technical product profile that includes defining critical quality attributes (CQA's) and critical processing parameters (CPP's)
o Support and review of SOPs/Document Management: documentation management and SOPs all instruction sets, specifications, batch records etc. and other Quality procedures directly related to operations and other cGMP activities
o On the floor Batch record review: Ability to review controlled documentation during processing for GMP and GDP
o Non-conformance/CAPA Management support and initial review of Non-conformances and CAPAs: Ensure all Non-conformances from established procedures are appropriately documented and investigated to determine and fix root cause; provide input on the creation and effectiveness of Corrective and Preventive Action plans and assist in determining a root cause
o In process sampling/ AQL sampling : Ensure all required assessment and testing is carried out to support Quality approval or rejection, as appropriate, for starting materials, packaging materials, intermediates, bulk and finished product
Required Education and Experience
Minimum B.S. degree in preferably microbiology, chemistry or biochemistry
- A minimum of 3 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, purification and aseptic fill/finish
o Experience with viral gene therapies and/or orphan disease indications is a plus
- Knowledge of FDA regulations and experience in US and international regulatory agency inspections
- Direct experience reviewing standard operating procedures and partnering with operations on product related investigations and Non-conformances
- Excellent oral and written communication skills with strong technical writing experience required
- Experience with internal audits