What are the responsibilities and job description for the Quality Assurance Specialist position at Lornamead Inc?
Quality Assurance Specialist
Lornamead is currently seeking a Quality Assurance Specialist to join our team! This position will support and maintain the Quality Management Systems at Lornamead.
Shift time: 11:00 a.m.- 7:30 p.m. (some flexibility available)
Lornamead, Inc. manufactures and supplies hair care, skin care, oral care, and bath products in America. The company offers toothpastes, teeth whitening products and oral analgesics for drug chains and national food retailers. The company is headquartered in New York, with a manufacturing facility in Tonawanda, New York.
Your Challenge:
- Document Control Expert: Responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Management Systems. Responsible for issuance, tracking, and control of change controls, Standard Operating Procedures (SOPs), Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions.
- Create and maintain all Certificates of Analysis (COAs) and other release documentation for finished goods supporting final release product for shipping. Submit completed COAs and other release documentation to the Quality Assurance Manager or designee for final approval.
- Assists with contract customers’ quality assurance items, including documentation, COAs, CAPAs, and deviation updates as requested.
- Ensure the calibration program remains updated and equipment owners are appropriately notified to remain in compliance
- Maintain Centralized Filing (Quality) and lead the archiving process.
- Act as Deviation Coordinator for processing nonconformities, including the issuance of deviation numbers and on time closures.
- Support in activities prior to, during and after external audits and inspections, as required.
- Analyze Quality function data to ensure site compliance.
- Support functions of the quality assurance group, including, but not limited to, batch record review, quality checks, incoming components and incoming raw materials.
- Maintain the Training Matrix and support Lornamead’s Training Program by assisting with employee training (cGMP Training, Change Control, Deviations, etc).
- Supports other tasks as delegated by the Quality Assurance Manager.
Qualifications:
- Bachelor’s Degree with 1-2 years of experience OR Associate’s Degree with 3-4 years of experience OR 6 years of equivalent experience in a QA role within a regulated industry.
- Knowledge of FDA Regulations and Health Canada Regulations for Drugs and Cosmetics preferred.
- Experience with Microsoft Word, Excel, Outlook, Teams required.
- Experience with electronic document management system and/or electronic quality management system preferred.
- Ability to multitask and prioritize in a dynamic work environment.
- Strong organizational, written/verbal and presentation skills.
- Ability to sit, stand, walk, and lift up to 30 lbs throughout an 8-hour shift.
Salary : $60,000 - $65,000