- Prepares, executes, and finalizes protocols (IQ, OQ, PQ, PVP and PVR) for validating current, new and improved manufacturing processes and products under minimal direction.
- Documents, coordinates the execution, and summarize qualification activities.
- Maintains existing protocols to be prepare for third parties review upon request.
- Coordinates planning, organizing, integration and completion of engineering project within assigned responsibility.
- Coordinates maintenance and contract administration duties.
- Supports in design and executes validation plans and programs for new and improved dietary supplement equipment.
- Manages the qualification schedule for the project and ensures deliverables are met and documented per the project plan.
- Occasionally supervises specialized contract personnel and outside vendors in the performance of contract validation services.
- Represents the company as the point of contact with regulatory agencies, including interface with the FDA inspectors.
- Evaluates existing equipment and processes, investigates and identifies new technology developments for ongoing improvements, including automation improvements, machine upgrades, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies.
- Provides technical input to Manufacturing, Quality and Reliability organizations for failure.
- Analysis, root cause and corrective action assessment, and technical training.
- Work with Production Supervisors to train production personnel on new equipment and processes.
- Works with consultant to optimize the current work load and process.
- Maintains working knowledge of current industry standards.
- Bachelor Degree in Engineering or equivalent work experience and education.
- Direct experience with analyzing and evaluating methods of production to efficiently allocate resources (equipment and labor) including time studies and line balancing.
- Knowledge of U.S. FDA, cGMPs, and QSR.
- Excellent written and verbal communications skills, as well as detail oriented organizational skills.
- Ability to utilize basic computer software such as Microsoft Office, Excel, Power Point, Word, and Outlook.
- Adapt in fast pace work environment and able to deal with multiple critical task/issues.
- 1-3 + years in Quality Engineering, Validation, Industrial Quality Control, and/or Quality Assurance.
- 0 - 3 years of work experience in dietary supplement, medical device, or other regulated industry.
What We Offer:
- Competitive Wages
- Medical & Dental (company pays 75% of employees HMO plans)
- Discounted Vision
- 401K - matching up to 3% of your annual salary
- Paid Holidays
- Vacation Days
- Sick Days
Robinson Pharma is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other protected status with respect to recruitment, hiring, promotion and other terms and conditions of employment. Robinson Pharma takes affirmative action in support of this policy to employ and advance in employment individuals who are minorities, women, disabled, and veterans.
Robinson Pharma, Inc will conduct a background check by using a third-party vendor to conduct such background investigations. After acceptance of an offer, you will be asked to complete and deliver authorization, consent and release of all background information. Employment will be 'at-will' and may be terminated at any time, with or without notice by either party in writing.
This is a full time position