What are the responsibilities and job description for the Quality Assurance Specialist position at Hygiena LLC?
Hygiena provides rapid microbiology diagnostic tests and solutions for mission-critical, time-sensitive processes around the world. Hygiena’s proprietary diagnostic technologies enable customers to; prevent illness and save lives, comply with regulations, protect products and brands, run businesses more effectively. Solutions are sold in a wide range of industries globally, but the core focus is food safety. Headquartered in Camarillo, California and with offices around the world, we are actively looking for talented individuals to help grow the business!
At Hygiena we believe:
- In providing the highest quality products & service
- Being a leader in innovation
- Having a compelling desire to improve and win in the marketplace
- In contributing positively not only in the workplace, but in our community and environment!
With rapid growth comes opportunity. We are looking for a Quality Assurance Specialist to join our team in Camarillo! This is a full-time exempt position.
Responsibilities:
- Standardize and continuously improve the Quality Management System (QMS) to ensure full compliance with regulatory requirements and industry standards. Draft, revise, and control critical quality documents, technical specifications, and operational forms in collaboration with management.
- Maintain and manage daily quality processes, including nonconformances, deviations, change controls, and risk assessments. Drive Corrective and Preventive Action (CAPA) and Supplier Corrective Action Requests (SCAR) from initial investigation and root-cause analysis through to action tracking, effectiveness verification, and closure.
- Support validation protocols (IQ/OQ/PQ) for production equipment, software, manufacturing processes, and utilities. Develop and maintain comprehensive validation documentation, final reports, and traceability records to ensure floor operations remain fully compliant with internal procedures.
- Participate in internal audits, supplier audits, and external audits/inspections as assigned; assist with audit preparation, documentation, and follow-up activities.
- Support complaint handling and investigation activities, including data collection, trend analysis, documentation, and escalation of quality issues when appropriate.
Qualifications:
- Bachelor’s Degree in Science, Engineering, Business or a related field required
- ISO 9001 or ISO 13485 Lead Auditor Certification preferred
- Minimum of two (2) years of direct, hands-on experience working in a fast-paced manufacturing or production environment required that includes the following:
- Experience within an ISO certified facility, preferably with ISO 9001 and/or ISO 13485
- Demonstrated experience executing root cause investigations, facilitating Corrective Action (CAPA), and handling customer complaint investigations
- Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required.
Salary Range (applicable to California):
$70,304-$85,000 base salary DOE
Skills/Abilities:
- Comfortable with interacting and working with all levels of customers, both internal and external; good interpersonal skills, team motivation and outgoing personality
- Excellent adaptability in a fast-paced environment with the flexibility and willingness to take on new tasks and projects
- Ability to speak and write clearly and accurately
- Attention to detail and accuracy
- Effective listening skills
- Multi-tasking capabilities
- Must have in-depth analytical and problem-solving skills.
- Must be able to use discretion and independent judgement.
Working Conditions:
- Is required to work normal office hours (with some flexibility as per the below) Monday through Friday in the Office
Physical Demand:
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
- This position is considered light work - exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. If the use of arm and/or leg controls requires exertion of forces greater than that for sedentary work and the employee sits most of the time, the job is rated for light work.
- Required to have close visual acuity to perform an activity such as: viewing a computer screen
- Frequently required to maintaining a static position, talking, hearing, seeing and repetitive motions.
Work Environment:
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
- The work environment is typical office or administrative work. Work environment is not substantially exposed to adverse environmental conditions.
- Clean room production setting (Basic 5-piece lab garments under cGMP)
Why you’ll want to join our team:
Teamwork as a core value.
At Hygiena, our emphasis on teamwork and cross-functional communication enables us to build stronger bonds within our business.
Be a part of something big.
Hygiena plays a critical role in helping to prevent global health crisis such as foodborne illness, healthcare-associated infections, and other outbreaks.
Giving back to our communities.
Hygiena believes in giving back by supporting local organizations committed to improving the lives of children and youth in our communities.
Benefits and Perks:
- 15 days of PTO & 9 paid company holidays
- Medical with HSA employer contribution, Dental, Vision available 1st of the month after start date
- Company paid Life Insurance, Short* and Long-Term Disability and an Employee Assistance Program
- 401(k) with Safe Harbor and Profit-Sharing employer contributions
- Tuition Reimbursement program
- Charitable Contribution matching
- Employee Referral bonus opportunities
*State paid short-term disability for California based employees
We are an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Hygiena participates in E-Verify
Salary : $70,304 - $85,000