Location: Novato,CA, USA
Onsite -OvernightDuties: Provide on-the-floor QA oversight and support manufacturing operations.Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations.Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.Represent QA in support of deviations including active participation in Root Cause Analysis (RCA).Provide cGMP and compliance guidance to Manufacturing and Technical Services (NTS) personnel.Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with policies.Perform area walkthroughs.Perform other duties and projects as assigned by management. Skills: Prior batch record execution or review experience.Prior experience in investigation, change control, other Quality Management Systems (QMS).Working knowledge of cGMPs.Excellent written and verbal communication and interpersonal skills. Must display strong analytical and problem-solving skills.Manufacturing and Manufacturing Sciences experience preferred.Education:BS/BA in a scientific discipline or related field and 3-5 year's experience in a biologics manufacturing environment.The hiring range for this position is $35 to $40 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.#ZR