QUALITY ASSURANCE ASSOCIATE

***/hr Pay Rate
Virtual Interviews
6 months possibly more covering a maternity leave
M-F 8:00am-4:30pm


This position will provide support to ensure the organization maintains compliance with Quality Systems, current Good Manufacturing Practices (cGMPs), current Good Tissue Practices (cGTPs), and in adherence with all applicable Federal, State, local, international, and industry regulations and standards. This individual will perform a variety of activities needed to establish and maintain compliance; including responsibilities associated with the quality assurance tasks.
Essential Responsibilities
Perform job functions in compliance with internal Standard Operating Procedures, Current Good Manufacturing and Tissues Practices, all Federal and State regulations and accrediting agency standards.
Assist in the management of the electronic document management systems including management of the site training records.
Review batch records and release products.
Assist with the initiation and risk classification of deviations.
Inspect and release incoming materials.
Ensure the electronic copies of SOPs, training materials, validation plans and other regulated documents are maintained.
Assist in the management of the library of printed documents, manuals and reference materials.
Work with departments to coordinate, schedule, and prepare for document release and training activities for new or revised procedures, competency assessments, annual GMP training and all other document release and training items as deemed necessary.
Assist in the creation of SOPs, forms, documents and training materials.
Assist in the creation, revision, and approval (for minor changes) of SOPs, policies, forms, etc.
Participate in customer and regulatory audits.
Assist the QA/RA department with process improvement activities.
Assist with special projects as assigned.
Perform all other duties, at the discretion of management, as assigned
Resolves conflicts with team members and involves functional management as required.

Supervisory Responsibilities
This position has no direct supervisory responsibility
Qualifications
To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily using the skills and abilities outlined in this job description. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Discretion in handling confidential and sensitive matters.
GMP manufacturing experience
Strong leadership skills with demonstrated ability to collaborate effectively across teams and functions
Strong verbal and written communication skills
Strategic thinking and excellent analytical skills
Excellent organizational, time management, and problem-solving skills
Ability to work well under deadlines and pressure
Knowledge and proficiency in navigating the electronic document control system
Education, Experience, and Licensure
Bachelor s Degree in Biology or related field.
2+ years experience in Quality Assurance role in a regulated environment; cGMP and cGLP Clean Room experience preferred.
Technical Skills
Proficient use of Microsoft Office products, including Word, Excel, Outlook, and PowerPoint.
Ability to quickly learn new software programs as needed.