Quality Assurance Specialist I

• Support configuration and training end-users on the electronic Quality System NCMRs Complaints OOS Change Control and CAPAs under guidance from senior team members
• Support data collection and author basic investigations with minimal guidance
• Assist with internal and external audits by preparing records gathering evidence and participating as needed
• Follow all Quality Systems requirements and support initiatives that contribute to Safety Compliance Quality On-Time Delivery (OTD) and continuous improvement goals
• Support training activities for quality and operations personnel by maintaining training records and assisting with scheduling
• Serve as a point of contact for internal Quality System questions
• Contribute to quality for new or existing products through activities such as data collection document drafting test method execution support or basic validation support (e.g. TMV configuration acceptance testing software equipment process or product)
• Compile metrics for quality monitoring and management review

• Embraces and models the Niowave Core Values of Teamwork Courage Integrity and Upright Zeal
• Bachelors degree or equivalent in science engineering or related field
• 1 years related experience or equivalent internship experience with an understanding of regulatory compliance related to operations and quality procedures
• Basic understanding of pharmaceutical quality requirements cGMP/GLP and general regulatory expectations.
• Moderate proficiency in Microsoft Word (styles table of contents section breaks formatting tools)
• Familiarity with PDF editing and publishing tools (Adobe Acrobat Pro)

• 2 years related work experience
• Quality or Regulatory certifications (CQE CQA CQM RAC) or willingness to pursue them
• Experience with lean manufacturing or continuous improvement tools (Six Sigma Lean 5S)
• Experience configuring and maintaining an electronic quality system
• Experience in a cGMP CDMO API or Finished Drug environment
• Experience in a facility with radiation regulatory requirements and/or quality role in the pharmaceutical or medical device industry.
• Experience in audits (internal NRC FDA etc.)
• Knowledge of the following regulations: ISOCFR 820 21CFR 210/211 Nuclear Regulatory Commission (NRC)

• Full-time position
• The companys standard operating hours are Monday thru Friday 6:00 a.m. 6:00 p.m. with production related activities requiring 24/7/365 shifts
• This position will have regular working hours Monday-Friday with an expectation of adjusting to meeting the shift work requirements for production and to meet with staff working outside of the standards operating hours
• Niowave has multiple locations within the Lansing area and travel between locations is expected in the role

Required Experience:

IC