Quality Validation Specialist
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Job Location:
Los Alamitos, CA - USA
Yearly Salary:
USD 100000 - 115000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Hims & Hers is the leading health and wellness platform on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable accessible and personal from diagnosis to treatment to delivery. No two people are the same so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions were making better health outcomes easier to achieve.
Hims & Hers is a public company traded on the NYSE under the ticker symbol HIMS. To learn more about the brand and offerings you can visit and . For information on the companys outstanding benefits culture and its talent-first flexible/remote work approach see below and visit the Role: The Quality Validation Specialist will serve as the subject matter expert (SME) and technical owner of the site validation and calibration programs within a sterile cGMP manufacturing environment. This role is responsible for authoring executing and overseeing validation protocols reports and supporting documentation to ensure facilities utilities systems and equipment are qualified and compliant with regulatory standards. The successful candidate will bring deep validation expertise the ability to build and continuously improve systems and a proven track record of technical problem-solving in sterile pharmaceutical operations. This individual will play a critical role in ensuring inspection readiness regulatory compliance and continuous improvement across validation programs. Lead and support commissioning qualification and validation (IQ/OQ/PQ) activities for facilities HVAC ISO 5/6/7 cleanrooms utilities and equipment in a sterile cGMP environment. Author review and execute validation documentation including protocols reports project plans risk assessments CAPAs deviations and change controls. Serve as SME for validation within the change control process providing technical oversight and guidance across cross-functional teams. Own and manage the site calibration program ensuring adherence to schedules and regulatory requirements. Collaborate with and oversee external validation consultants including scoping scheduling and reviewing deliverables. Develop implement and drive continuous improvement of validation and calibration systems applying industry best practices and regulatory standards. Develop and report on key metrics related to areas of responsibility including statistical analysis as needed. Own quality investigations change controls and project related to areas of responsibility. Assist in developing monitoring and acting on process data to drive continuous improvement. Support audit and inspection readiness by presenting validation activities to regulatory authorities and customers; lead responses and corrective actions for findings. Partner with Quality Manufacturing Engineering and site leadership to resolve technical issues support process improvements and foster a culture of compliance. Apply good documentation practices (GDP) and good engineering practices (GEP) in all activities. Maintain and demonstrate expertise in applicable regulatory requirements (FDA ICH ISPE) and ensure compliance with cGMP cGxP and 21 CFR Parts 11/210/211. B.E. / B. Tech in Mechanical Chemical or related engineering discipline from a recognized university (or equivalent). Minimum 3-5 years of relevant validation experience in pharmaceutical or biotech sterile cGMP environments. Proven expertise in facility equipment and utilities qualification including sterile manufacturing and cleanroom/HVAC systems. Strong technical knowledge of process utilities instrumentation and engineering fundamentals and an ability to analyze and resolve situations that arise in the commissioning and qualification of a sterile injectable facility. Demonstrated ownership of validation and calibration programs. Experience with commissioning/qualification lifecycle deliverables (URS FS FAT SAT DQ IQ OQ PQ). Working knowledge of industry regulations and guidance (FDA ISPE ICH Q7-Q9 Annex 11 Part 11). Experience supporting regulatory inspections and audits with successful outcomes. Strong background in change controls investigations and root cause analysis methodologies. Experience with the application of risk management tools and risk-based decision making. Experience with statistical process control (SPC) leading process improvement projects and continuous process verification (CPV) preferred. Experience working with and/or qualifying automated equipment preferred. Excellent technical writing communication and cross-functional collaboration skills. Demonstrated ability to independently prioritize problem-solve and deliver results in a fast-paced environment with minimal supervision and high accountability. Knowledge of Sterile formulation engineering Knowledge of USFDA cGMP GLP ISPE ISO Risk Management Project Management Planning & Execution of qualification and calibration activities Competitive salary & equity compensation for full-time roles Unlimited PTO company holidays and quarterly mental health days Comprehensive health benefits including medical dental & vision and parental leave Employee Stock Purchase Program (ESPP) Employee discounts on hims & hers & Apostrophe online products 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics wellness and a strong sense of belonging. If youre excited about this role we encourage you to applyeven if youre not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment including applicants with arrest or conviction records in accordance with the San Francisco Fair Chance Ordinance the Los Angeles County Fair Chance Ordinance the California Fair Chance Act and any similar state or local fair chance laws. 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. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability please contact us at and describe the needed accommodation. Your privacy is important to us and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status including disability. Please do not send resumes to this email address. To learn more about how we collect use retain and disclose Personal Information please visit ourGlobal Candidate Privacy Statement. Required Experience: Unclear SeniorityYou Will:
You Have:
Our Benefits (there are more but here are some highlights):
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
Hims is a one-stop telehealth service for men's wellness and care, providing treatment options for hair loss, ED & more.
