- High School diploma or equivalent
- 2-5 years experience in related field
- Knowledge of FDA/cGMP guidelines
- Computer literate in Microsoft Windows and Microsoft Office
- Working knowledge of Oracle and Agile
- Excellent analytical and problem-solving skills, with a focus on continuous improvement and process optimization
- Strong communication and interpersonal skills, with the ability to collaborate effectively
- Fluent in English, Spanish a plus
- Strong verbal and written communication skills
- Supervise and coordinate all quality assurance activities during the 2nd shift, including inspection, testing, and documentation, in accordance with Good Manufacturing Practices (GMP) and regulatory guidelines
- Lead a team of Quality Assurance Inspectors, providing guidance, training, and performance feedback to ensure adherence to quality standards and procedures
- Investigate and resolve quality issues, non-conformances, and deviations in a timely and effective manner, implementing corrective and preventive actions as necessary to maintain product quality and regulatory compliance
- Oversee that all in-line checks for count, labeling, seal integrity and overall package quality are monitored accurately and within designated times as slated in our SOP
- Write NCMR's as required
- Review Batch Record for missing entries and errors
- Ensure appropriate AQL were used and met
- Review daily, line operations to assure compliance with cGMP's and SOP's
- Review cleaning log books to assure the proper cleaning has taken place
- Investigate and discuss non-conformities with Inspectors
- Monitor QA personnel daily start and stop times
- Interact with company personnel as required to remedy problems related to packaging production or product quality and batch record reconciliation variances
- Assist in Process Validation as required
- Report any non-conformities or facility observations to the Manager
- Write and/or assist with deviation and investigation reports as necessary
- Participate in APRs, Audits, Production and Quality meetings as required
- Write annual employees reviews
- Must have a clear understanding and be able to verify all documentation recorded and documented by compounding personnel.
- Understanding of adjustments to temperature, time, and speed controls required by (CF) compounding formulas. To be able to review ingredients and specifications for blending cycles as specified on (CF) compounding formula.
- Able to work with R&D, Validation departments on reformulation and development of new products.
- Experience with characteristics of batches and raw materials preferred.
- Drive a culture of quality and continuous improvement while fostering collaboration, accountability, and excellence in adherence to regulatory requirements and industry best practices
- Assist Quality Department as needed
- Ability to stand, walk, and move around the production floor for extended periods.
- Occasional lifting of boxes, files, or other materials weighing up to a certain weight limit, typically not exceeding 25-30 pounds, to retrieve or organize documents or supplies
- Manual dexterity and hand-eye coordination for handling equipment and performing inspections
- Ability to utilize required personal protective equipment (PPE)
- Visual acuity and color vision for conducting visual inspections of products
- Occasionally climbing stairs or laddersAbility to work in a fast-paced environment with exposure to noise, chemicals, and other potential hazards associated with pharmaceutical manufacturing and packaging operations
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Quality Assurance Supervisor - Piedmont, United States - PL Developments
