Job Title: Quality Assurance Specialist
Reporting Relationships: Quality / Regulatory Manager
Status: Full-time, Exempt
Hours: Flexible, on-site/remote
Department: Quality Assurance
Job Summary & Purpose:
The Quality Assurance Specialist monitors conformance to quality assurance standards and established organizational procedures. Responsible for supporting and evolving formal quality processes, ensuring that the team is using industry-accepted best practices. Work closely with all manufacturing functions to execute assigned responsibilities and drive improvements to the methodologies and processes employed by these functions. Responsible for (and may not be limited to) quality functions listed below and identifying improvement opportunities for these functions.
· Coordinate supplier management process, documentation and periodic updates to score cards.
· Coordinate and maintain document control processes.
· Coordinate and maintain training program.
· Conduct nonconforming product inspections and facilitate disposition as needed.
· Review batch records and quality certificates as needed.
· Support quality functions such as deviations, CAPAs, audits, validations and equipment qualifications.
· Drive quality records and investigations to a defined point of completion/closure.
· Report regularly on trends and high-priority quality events.
· Support change and transfer processes.
· Stay current with all Regulatory Standards (and/or any other quality standards that affect the company and its customers) and how they apply to Grace Bio-Labs, particularly those which directly deal with your responsibilities.
· Maintain confidentiality for all customer records and correspondence.
· Mentor GBL team members in the use of the quality software systems.
· Work safely and follow all safety protocols.
· Communicate effectively and work well with others.
· All other duties as assigned by manager / supervisor.
· Must have 4 years of on-the-job experience in one or more of the areas of the quality field.
· Four-year college degree preferred, two-year associates degree minimum.
· Statistical processing and interpretation of data (preferred).
· Safety and regulatory requirements for the position (preferred).
· Ability to multi-task/prioritize in an efficient and organized manner.
· Use of business system software (proficient in MS Office).
· Use of quality system software (preferred).
· Ability to maintain a positive attitude amid potentially high-stress situations.
· Outstanding communication skills.
· A keen eye for detail and a results-driven approach.
· Work will be in shared office space in a typical office environment
· Some work will take place in the production environment. Specialized attire is required in environmentally controlled spaces including scrubs, lab coat, hair net and other protective clothing.
Physical Demands & Work Environment:
· Use of computer, phone, office equipment.
· Odor free environment (smoke-free, fragrance free).
· Long hours on a computer with typing and data entry. (Use of wrist and motor skills).
· Represent GBL in a professional manner (attire, speech, and grooming).
· Use of stairs as required.