Quality Assurance Associate

Kelly Science, Engineering, Technology & Telecom; Los Angeles (CA); In loco; USD 41.328; Tempo pieno

Descrizione del lavoro

A staffing agency is seeking a QA Associate in Northridge, CA. This role involves ensuring compliance with Quality Systems and conducting quality assurance tasks. Ideal candidates will have a Bachelor’s Degree in Biology or a related field, along with 2+ years of experience in a regulated environment. Strong communication and leadership skills are essential. The position offers a pay rate of $30/hr, with virtual interviews available.

Competenze

• Ability to handle confidential matters discreetly.
• 2+ years’ experience in a Quality Assurance role in a regulated environment.

Mansioni

• Ensure compliance with Quality Systems and regulations.
• Perform quality assurance tasks and maintain compliance.
• Assist in managing electronic document systems.

Conoscenze

GMP manufacturing experience

Strong leadership skills

Strong verbal and written communication skills

Strategic thinking

Excellent organizational skills

Problem-solving skills

Formazione

Bachelor’s Degree in Biology or related field

Strumenti

Microsoft Office

Descrizione del lavoro

Kelly is hiring a QA Associate for one of our clients in Northridge, CA

• $30/hr Pay Rate
• Virtual Interviews
• 6 months possibly more covering a maternity leave
• Mon-Fri 8:00am-4:30pm

Summary

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.

• 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.

Language Skills

Must have a good command of the English language and be able to communicate clearly and concisely in both written and verbal format.

Mathematical Skills

Must be able to analyze and present quantitative data. Able to accurately compute basic mathematical equations such as addition, subtraction, division, multiplication, and percentages.