Quality Assurance Associate

Website Grace Bio Labs

Job Title:  Quality Assurance Associate


Reporting Relationships: Quality / Regulatory Manager

Status: Full-time, Exempt

Hours: Flexible, On-Site

Department: Quality Assurance

FLSA: Exempt


Job Summary & Purpose:

The Quality Assurance Associate is a Quality team member, working to monitor 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.

Essential Functions:

·         Coordinate supplier management process, documentation and regular updates to score cards.

·         Maintain document control processes and participate in revising Standard Operating Procedures.

·         Maintain training program.

·         Conduct nonconforming product inspections and facilitate disposition as needed.

·         Documentation review of batch records and quality certificates for product release in compliance to internal specifications.

·         Support quality activities such as deviations, CAPAs, RMAs, 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.

·         Coordinate product 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 in office environments and laboratory spaces.

·         Communicate effectively and work well with others.

·         All other duties as assigned by manager / supervisor.


Minimum Qualifications:

·         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).

·         Use of business system software (proficient in MS Office).

·         Intermediate to advanced proficiency in MS Excel (preferred).

·         Use of quality system software (preferred).

·         Ability to multi-task/prioritize in an efficient and organized manner.

·         Ability to maintain a positive attitude amid potentially high-stress situations.

·         Outstanding communication skills.

·         A keen eye for detail and a results-driven approach.

Working Conditions:


·         Work will take place in a shared office environment and in production spaces.

·         Specialized attire is required in environmentally controlled spaces including scrubs, lab coat, hair net and other protective clothing.


Note: Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

To apply for this job please visit gracebio.com.