Quality Control Specialist

About the Role

We are looking for a highly motivated individual to help support and report to the Senior Manager Quality Operations. The Quality Control Operations Specialist role is responsible for the inspecting and/or testing of product(s) before, during and after manufacturing process(es) to ensure products align with company and regulatory standards, as well as other processes necessary to quality operations.

The position performs and leads activities "on the floor" in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, USP, SOPs, and where applicable cGMP.

Shift: Sunday - Wednesday 5:30pm - 4:00am

You Will

• Perform in process and post production quality checks, including testing, assessing and dispositioning products in the production suites (“shop floor”) to ensure product acceptability.
• Provide reports and trending data to QA management Support departments in reporting, handling and escalation of investigations
• Support external manufacturer non-conformance investigations to improve Hims Quality processes.
• Manage Hims Product Retains and inspections Support change control system to provide improvement solutions Support quality processes in the pharmacy - including testing inspections, verification of pH meters and scales, non-conformance/deviation/complaint investigations, implement corrective action activities, training activities, etc.
• Document & review of records: SOP generation, batch record review, COA acceptance, USP monographs, etc.
• Detect training needs, provide reports to Site Manager to ensure compliance with quality standards
• Assist with incoming raw material inspections: Implement procedures of sampling (where applicable) and guidelines for collection, testing, and reporting quality data
• Assist with drafting SOPs and protocols to follow internal policies, USP and other applicable regulatory guidelines Ensures compliance with USP <795> and cGMP cleaning standards
• Assist in audit activities with all appropriate third party audits & internal audits as required to ensure compliance.
• Assist with the management and reporting of samples to be tested with contract laboratories.

You Have

• B.S. in chemistry, biology, quality management, engineering, or related discipline preferred.
• 2+ years experience in the area of quality assurance/control, process engineering, and/or product formulation
• Experience within a 503b outsourcing facility Aseptic processing experience and knowledge of ISO 14644 Working knowledge of USP-NF standards <795>, <797>, <800> including monographs Experience in cGMP or regulated environment with knowledge of FDA 21, CFR 210, and 211 a plus Excellent interpersonal skills and communication skills (verbal and written)
• Solid understanding of product testing including understanding best practices for testing product against defined specifications
• Ability to multi-task and work independently.
• Highly motivated self-starter. Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook. MRP, Excellent skills in decision making, data collection and analysis, organizing and planning.
• Working knowledge and application of statistical analysis including probability and trend analysis Knowledge and experience in technical writing Knowledge and experience in Auditing
• Some travel may be required

Benefits

Our Benefits (There Are More but Here Are Some Highlights):

Offering competitive benefits are a top priority for our company; we are extremely proud of the benefits we are able to offer to employees. Some of the benefits our team members are able to enjoy include:

• A dynamic, open & honest culture of collaborative co-workers where diverse perspectives are welcome & valued
• Competitive pay with equity compensation
• ESPP Plan
• Flexible PTO
• Holidays observances
• Quarterly Mental Health Days
• High-coverage medical, dental & vision (FSA & HSA plan options)
• Pet Insurance
• One Medical Membership
• Disability Benefits
• Employee Assistance Program
• Life and AD&D Benefits
• Fitness stipend
• Backup childcare
• Family forming resources

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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