Quality Assurance Specialist

About OSRX Inc.:

OSRX, Inc. is a closed door compounding pharmacy located in Missoula, MT that proudly zigs where others zag. We envision an industry that is patient friendly and solution-driven. Our state-of-the-art compounding pharmacy improves the patient experience by compounding multiple medications into a single bottle to streamline dosing. This simplicity reduces barriers to use and promotes easy adherence.

We do this because we believe in putting patients ahead of profits. In engineering simple solutions to solve complex problems. In disrupting the status quo. We have A New View of Medicine®.

Job Description:

OSRX Inc. is seeking a full-time Quality Assurance Specialist to join our team. The Quality Assurance Specialist performs review activities of finished good compound medications to ensure compliance with applicable SOPs and regulatory requirements prior to final release of product. Our ideal candidate will have a science background and previous quality assurance and pharmacy experience. The Quality Assurance Specialist typically work in 8 hour shifts Monday - Friday.

Job Responsibilities:

• Works in accordance with department supervision to provide quality assurance oversight where the business is responsible for adhering to good documentation practices including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, and product distribution as applicable
• Ensures company compliance to Standard Operating Procedures (SOPs) and regulatory guidelines
• Ensures all work is performed and documented in a timely manner and according to approved standard operating procedures and general compliance
• Store, manage and track company documents
• Scan, image, organize and maintain documents, adhering to the company’s document lifecycle procedures
• Supports department supervision in oversight and prioritization of day-to-day responsibilities.
• Timely identification, and resolution of events potentially impacting the Quality of products and processes
• Reviews routine compounding, environmental monitoring and quality control data for in-process and finished products
• Evaluation of batches / product for compliance with defined specifications
• Sampling, inspection, and control of compound medication labels
• Review and approval of shipping documentation for compound medications
• Other duties as designated by the department supervisor

Job Qualifications:

• Strong computer skills (Excel, Word, Adobe), required
• Familiarity with document databases and repositories, preferred
• Prior batch record/document review, preferred
• Experience in Quality Assurance, Sterile Compounding and/or FDA regulated industry, preferred
• Willingness to be cross-trained on Quality Assurance tasks
• Highly motivated, self-directed and the ability to work independently
• Ability to work as a team member, maintaining day to day activities while being responsive to changing priorities
• Strong interpersonal, communication and customer service skills
• Attention to detail and organizational skills
• Ability to prioritize, manage time well, multitask and troubleshoot
• Ability to work in a high demand & output environment
• Ability to stand for a long period of time
• Ability to lift/carry 15-20 lbs

Hourly wage of $18-$23. Must pass a background check prior to hire. Benefits include health, dental, vision, life, disability, 401K, holidays, and paid time off after qualified employment term.

Work Location:

• One location

Work Remotely

• No

Job Type: Full-time

Pay: $18.00 - $23.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Application Question(s):

• Are you able to pass and willing to complete a background check?

Education:

• Bachelor's (Preferred)

Experience:

• GMP: 2 years (Required)

Work Location: In person

Salary : $18 - $23