What are the responsibilities and job description for the Quality Assurance Specialist position at Biotics Research Corporation?
For over 40 years, we have been at the forefront of the nutrition industry, renowned for our top-quality supplements and innovative product delivery systems. Our commitment to advancement is driven by our focus on research initiatives, unique product formulations, and unparalleled quality control. As a family-owned company with a rich history, we take pride in our valued partnerships with healthcare professionals, ensuring that our products meet the highest standards of excellence.
This is a mid-shift position Monday-Friday 8a-4:30p This position is responsible for supporting the Quality Assurance Supervisor and ensuring products are manufactured in accordance with FDA regulatory requirements as well as company procedures and policies.
- Oversees QA Inspector daily activities with focus on product quality and regulatory compliance.
- Working with the QA Supervisor to Coordinate and schedule QA employee orientation, training, certification and skill advancement.
- Serves as a technical resource, within the plant, by assisting personnel with quality questions and problem solving.
- Assist with creating and training on new and/or modified SOPs.
- Assisting the QA Supervisor with making daily departmental changes, where necessary, to maintain successful performance.
- Working with the QA Supervisor to coordinate QA activities and to strategically address non-compliance trends.
- Ensure the company quality standards and product integrity are maintained throughout the manufacturing process.
- Assisting with customer complaints and associated investigations.
- Ensuring all relevant manufacturing employees receive GMP training.
- Ensure preparedness for regulatory inspections/audits and participate in regulatory inspections/audits as needed.
- Assist with Biotics product notification obligations both for USA and international markets.
- Meet regularly with department leadership teams to address quality assurance issues and process improvements.
- Performs and supports execution of Investigations, CAPAs and Change Controls.
Work Requirements and Skills
- A four-year degree in life science is required
- 2 years of previous or similar work experience is required
- Must have good organizational, time-management, and project management skills
- Must have strong written, verbal, and interpersonal communication skills
- Must have strong people leadership skills
- Must have basic computer skills including MS Office applications: Word, Excel, Powder Point and Google mail
- Must demonstrate flexibility when re-prioritization is necessary
- Must be able to work overtime, or a modified schedule, when the company deems it necessary
- Must be able to wear the necessary, job-related personal protective equipment
Ability to lift (up to 50-lbs), stand, walk, bend, crouch, reach, stretch, step and climb occasionally during the duration of the shift
Benefits
- 401(k) and contribution from company
- Incentive pay
- 16 days of paid time off and paid holidays
- Life and short/long-term disability insurance
- Professional development assistance
- Health, dental, and vision insurance
- Flexible spending account
- Referral program
- Career growth path
- In-house product allowance
