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Quality Assurance Specialist

OSRX, Inc.

Missoula, MT

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JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Cleanroom, Communication Skills, Continuous Improvement, Current Good Manufacturing Practice (cGMP), Detail Oriented, Document Management, Documentation, Environmental Monitoring, Equipment Validation, Insurance, Life Insurance, Lift/Move 25 Pounds, Manufacturing, Microsoft Office, Operational Support, Presentation/Verbal Skills, Problem Solving Skills, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Regulations, Standard Operating Procedures (SOP), Toxicology, Trend Analysis, Writing Skills
LOCATION
Missoula, MT
POSTED
30+ days ago
Job Responsibilities:- Review and approve production batch records, and logs for accuracy, completeness, and compliance prior to product release.- Perform line clearance in manufacturing areas.- Participate in deviation and nonconformance investigations.- Review and maintain controlled documents, including Standard Operating Procedures (SOPs), forms, logs, and specifications.- Review and approve vendor qualifications, certificates of analysis (COAs), and raw material release documentation.- Perform environmental and personnel monitoring sampling.- Monitor environmental and personnel monitoring data to ensure state of control within the cleanroom.- Assist with training activities to ensure staff are qualified and maintain competency for cGMP operations.- Support validation activities (equipment, process, analytical, and cleaning) as part of ongoing quality oversight.- Maintain quality metrics, trending, and reports as part of the continuous improvement process.Education and Experience:- Experience in Quality Assurance or Quality Control- Experience with cGMP or USP preferred- Familiarity with sterile compounding operations and aseptic processing principlesSkills and Competencies:- Strong attention to detail, organization, and documentation accuracy.- Ability to interpret and apply cGMP regulations and quality standards.- Excellent written and verbal communication skills.- Proficiency in Microsoft Office Suite- Strong problem-solving skills and ability to work both independently and collaboratively.Working Conditions:- Standard Schedule Options: 8 Hour shifts: 7:00am-3:00pm or 10:00-6:00pm Monday - Friday or Tuesday - Saturday. Some roles may require rotating Saturday coverage based on operational needs.- Work performed in both office and classified cleanroom environments.- May require gowning and adherence to aseptic gowning qualifications.- Occasional lifting (up to 25 lbs), standing, or walking for extended periods in controlled environments.- Must pass a background check and toxicology screening prior to hire.- Benefits offered after qualified employment term: 401k match, Medical Insurance, Dental Insurance, Vision Insurance, Term Life Insurance, STD Insurance, and Paid Time Off.

About the Company

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OSRX, Inc.