Job description
About Us:
Position Summary
The Quality Validation Engineer helps facilitate the quality management system by assuring company standards are maintained and product integrity is preserved. The employee complies with company policies and procedures, and GMP, OSHA, Federal, State, and Local regulations. Specifically, the Validation Specialist will be responsible for manufacturing process validations including the preparation of protocols and reports as well as tracking the implementation of required actions as a result of qualification/validation activities. Additionally, the Validation Specialist will participate in PRL’s quality investigation systems, internal audit program, and contribute to continuous improvement projects.
Essential Functions
For over 30 years, Premier Research Labs (PRL) has offered uncompromising, beyond the state-of-the-art nutritional products, seminars, and services to the health professional community across the U.S. and internationally. PRL offers a full line of premium quality, professional nutritional supplements, and super foods. With our dedication to excellence, we insist our nutritional products meet the highest quality standard for safety, purity, efficacy, quality, and bioenergetic testing.
We are proud to state we are USP and NSF certified. PRL is one of only a handful of companies in the entire U.S carrying both certifications. This means we meet the strict standards to be the “Rolls Royce” of dietary supplement manufacturers. That’s why our motto is “The World’s Leader in Cellular Resonant Formulations”. Our mission is to provide premier quality, cellular resonant, nutraceutical formulas, and lifestyle strategies for our clients.
We have a great company culture with a friendly, highly motivated staff that is dedicated to creating premier quality nutritional supplements and natural food products that truly make a difference in people’s lives. We are not requiring vaccinations for our staff. Become a part of our awesome team!
Position Summary
The Quality Validation Engineer helps facilitate the quality management system by assuring company standards are maintained and product integrity is preserved. The employee complies with company policies and procedures, and GMP, OSHA, Federal, State, and Local regulations. Specifically, the Validation Specialist will be responsible for manufacturing process validations including the preparation of protocols and reports as well as tracking the implementation of required actions as a result of qualification/validation activities. Additionally, the Validation Specialist will participate in PRL’s quality investigation systems, internal audit program, and contribute to continuous improvement projects.
Essential Functions
- Experience and in-depth understanding of all system lifecycle deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements Specifications (UFRS), Design Qualification (DQ), Process Validation (PV), Qualification Test Protocols (IQ/OQ/PQ), and support documentation (SOP development, Preventive Maintenance, calibration, etc.).
- Technical writing, document control, and organizational skills a must.
- Ensure all executed protocols meet internal and cGMP requirements.
- Collaborate with Operations, Quality and other functional areas on validation study implementation which may require off-shift and weekend execution.
- Actively participate in cross-functional teams and lead project initiatives to ensure that the projects are delivered on time meeting the required quality standards.
- Support the quality systems as needed.
- Other work as assigned.
Education & Experience
- Bachelor’s degree in Engineering, Life Sciences, or other related technical field with two or more years experience in pharmaceutical, Dietary Supplement, or other regulated industry.
- This position requires 2+ years documented success in a Quality role within a cGMP manufacturing environment. Knowledge in Quality processes is normally acquired by the attainment of a 4-year college degree in Quality or a Science discipline (Engineering, Biology, Chemistry, etc.) equivalent, in combination with relevant work experience.
Core Competencies
- Result driven and self-motivated
- Continuous improvement and problem-solving attitude
- Strong interpersonal and communication skills (verbal and presentation)
- Strong computer literacy such as MS Project, Excel, etc.
- Ability to handle a high-pressure, high-stress work environment
Work Environment
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is in an office environment and routinely uses standard office equipment which may include lifting up to 25 pounds for extended periods of time throughout the day.
- This position involves sitting for extended periods of time, however, may be exposed to manufacturing areas where moving mechanical parts and heavy machinery are located.
Work Schedule
- Monday-Friday, 8:00am-5:00pm (shifts may vary based on needs of the company)
- Occasional overtime may be required
- Some travel may be required
Employee Benefits:
PRL is committed to help support employees by offering company benefits.
PRL is committed to help support employees by offering company benefits.
- Paid Time Off
- Competitive Compensation
- Paid Holidays
- Healthcare insurance
- Dental and Vision insurance
- Life Insurance
- 401(K) retirement program with company match
- HSA (Healthcare spending or reimbursement account)
- Employee product discounts
- A great company culture with a teamwork attitude
- Excellent managers who really care about their staff
Compensation:
- $65,000-$75,000 per year, dependent on experience
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