We are seeking an energetic Quality Assurance Manager who will be responsible to assure products are manufactured, tested, and released in accordance with relevant GMPs. As a leader, you will recommend and champion quality improvements and changes to development processes, procedures, and work products to correct deficiencies and noncompliance. This role incorporates operation and maintenance of quality systems for the Proteintech US and Humanzyme location in Rosemont, IL near Chicago.
We have recently begun construction of a new ISO 6 and 7 suite to support production of highly authentic recombinant human proteins from human cells. The existing operation will be transferred from our legacy Humanzyme facility in Chicago to our new xxx sq ft production suite in Q1 2019. This role will assist the qualification of transfer while ensuring the new facility operates under cGMP principles and requirements.
Planning, developing, and implementing ISO and cGMP compliance elements to enhance the Quality Management System.
Project management to execute implementation plans, and drive quality objectives and goals.
Leading regulatory and customer audits and resolving customer complaints.
Essential Job Functions:
Oversees the review of all documentation related to product manufacturing, packaging and testing prior to distribution.
Generates, maintains, and reviews SOP's related to production and Quality operations.
Manage external customer assessments from scheduling to audit close outs.
Investigates and reports on customer complaints, CAPAs, and DRs.
Responsible to establish the Validation strategy for new processes/equipment and translates those requirements to appropriate validation protocols and standard operating procedures.
Develops, maintains and updates the Validation Master Plan (VPM) for the site.
Understanding of qualification of equipment/processes, computer-related system qualification and calibration program management.
Develop and deliver quality training for manufacturing and support function personnel based on working knowledge of ISO, CFRs, and SOPs. Supports cGMP training programs to ensure staff is being trained; Actively supports the Quality culture as a role model.
Responsible for measurement and analysis of Quality System trends, OOT, and OOS.
Execute internal audits to ensure compliance at all times.
Qualification And Skills Required
Bachelor, Master degree or PhD in Chemistry, Biotechnology, Life Science or related field
5-8 years of relevant pharmaceutical/ biotechnology/ life science work experience; prefer 2-3 years of relevant cGMP or ISO quality system manufacturing environment
Knowledge of ISO, FDA, cGMP’s, and CFR requirements
Demonstrated knowledge of quality systems (i.e., CAPA, change control, product complaints, etc.) and their implementation
Ability to oversee project execution to identify non-compliance from quality standards
Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive
Strong team orientation; a coaching versus a policing orientation
Excellent verbal, written and interpersonal communication skills
Preferred Qualification And Skills Required
Experience and knowledge of cell culture development, manufacturing, or testing
General knowledge of manufacturing processes
Experience with analytical methods transfer and scale up
About Proteintech Group Inc.
Proteintech Group is an original manufacturer of primary antibodies, proteins, and Humankine proteins, their line of human cell-expressed proteins. Proteintech has produced over 14,000 antibodies with unparalleled high quality against 14,000 different human whole proteins and over 50 animal-free, xeno-free, human-cell expressed proteins allowing for native human glycosylation, folding and maturation. Our worldwide locations in US, China, Europe, and Japan have every antibody in stock and offer next day delivery.