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LPNA GROUP INC

QA Specialist

LPNA GROUP INC Tonawanda, New York, United States · $60K–$65K/yr

Personal Care Product Manufacturing · 51-200 employees

4 h ago
qa Mid (2-5 yrs) Full-time United States
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About the role

The QA Specialist is responsible for managing quality documentation, change controls, and deviation processes to ensure site compliance. They also support external audits, maintain training programs, and perform quality checks on raw materials and finished goods.

What they look for

Quality Assurance Document Control Change Management SOP Development Calibration Program Management Deviation Coordination Audit Support Data Analysis cGMP Training Batch Record Review Microsoft Word Microsoft Excel Microsoft Outlook Microsoft Teams FDA Regulations Health Canada Regulations

Requirements

Candidates must have a Bachelor's degree with 1-2 years of experience, an Associate's degree with 3-4 years of experience, or 6+ years of equivalent experience in a regulated industry. Proficiency in Microsoft Office and knowledge of FDA and Health Canada regulations are required.

Full description

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)

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.

About Lornamead Products

Lornamead is a diversified manufacturer and marketer of specialty oral care and personal care products with a portfolio of several iconic heritage brands, including Yardley London, Finesse, Aqua Net, and Lypsyl. The Company is the leading supplier of private label oral care products to retailers across North America. Lornamead is headquartered in Tonawanda (Buffalo), New York. For more information, please visit www.lornameadproducts.com.

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