Quality Assurance Associate - ELITechGroup Inc.

A successful biotech company is looking for a motivated and detail-oriented team member to join our Quality Assurance team.

At ELITechGroup, we are committed to supporting health systems globally. During the Covid pandemic, we played a significant role in the global effort by being one of the first companies to offer PCR diagnostic solutions in Europe. We take pride in our team and strive to maintain a work environment that is both professionally challenging and personally fulfilling.

As a valued member of our team, you would contribute to the manufacturing and distribution of in vitro diagnostic products to clients in over 100 countries. You will have the opportunity to work alongside some of the brightest minds in the industry, as our team is dedicated to solving problems and delivering excellent products.

This position is ideal for someone interested in the biotech industry, who takes pride in learning all aspects of the job and adhering to procedures and standards. You will receive guidance from a supportive team that will ensure you are trained and capable of performing your responsibilities effectively.

Job description:

The Quality Assurance Associate position plays a key role in supporting the cGMP quality operations for Manufacturing. Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, specifications, completed batch records, material disposition, and manages implementation of required changes to meet cGMP and internal standards.

The primary focus of the QA Associate role is to support commercial production to ensure consistent compliance with regulatory and industry expectations. Assist the QA department in maintaining the Quality focused culture by ensuring documentation is complete, accurate and that Batch records are executed in accordance with approved and effective standard operating procedures and specifications.

Key Responsibilities:

• Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
• Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
• Review deviations, product non-conformities, and GMP investigations to ensure adequate completion.
• Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
• Support the review and approval of incoming raw materials, and calibration of equipment.
• Revise Standard operating Procedures as needed.
• Participates during audits (FDA, ISO, vendor)
• Participate as member of the internal audit team.
• Assists with validating spreadsheets for development and production.
• Assists Document Control, (assign CC and document numbers, assist in obtaining approvals, auditing external documents, etc.) when necessary.
• Other duties and task as assigned.

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

Organizational Support - follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values.

Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality.

Written Communication - writes clearly and informatively; able to read and interpret written information.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelor's degree in relevant science or engineering discipline is preferred. Minimum of Associates degree and/or equivalent combination of education and experience is required.
• Minimum of 2 years' experience in working in a FDA or ISO regulated environment or equivalent training.
• Knowledge of ISO 13485, ISO 9001, cGMP and FDA QSR preferred.
• Hands-on experience with batch record review and product disposition is preferred.

On our end, we provide comprehensive medical dental and vision insurance subsidized by the employer. On top of that, we provide life insurance, long term care insurance at no cost to employees, and we match up to 5% of your 401k contributions. To ensure a good work life balance, we provide 11 company paid holidays and 3 weeks of PTO in your first year, which increases with your tenure. But most of all, you will get to work with talented, enthusiastic, and positive professionals who will make it impossible for you to have a bad day at work and support you in your success and growth.