The QA Associate role is essential to our commitment to high quality and success through supporting core Quality System requirements and implementation of strategic initiatives for improved efficiency, productivity and compliance. The QA Associate will work closely and collaboratively with Quality, Chemist and Leadership staff on projects to accomplish organizational goals and maintain the Quality Management System in a cGMP compliant contract laboratory environment. Our ideal candidate is a very positive person that embraces challenges as opportunities, is a detailed planner, great communicator, builds strong co-worker/customer relationships and is a top-notch technical writer.
- Perform quality oversight of the equipment management process (initiating new equipment, PMs, Calibrations, Qualifications, logbook reviews).
- Perform QA reviews of issue handling processes (IN/NCR/CAPA).
- Revise SOPs and other procedures related to the Quality System with the goals of continually improving our processes for increased modernization, efficiency and compliance.
- Review quality system revision drafts to facilitate compliance, process clarity and efficiency improvements being driven by lab staff and others.
- Participate in the creative improvement of the VR training program.
- Assist with the customer audit cycle, specifically by helping design Corrective Actions, setting timelines and ensuring the completion of those actions on the timelines communicated.
- Assist with performing supplier audits.
- Assist with Quality Record archival process.
- Support implementation projects such as new instruments / equipment / facility expansion.
- Become proficient in the applicable regulations (21 CFR Parts 11, 210, 211) and aid VR Analytical’s continuing compliance.
- Assist others in closing high risk compliance gaps sufficiently under the goal of FDA inspection readiness.
- Monitor the timely completion of routine Quality System requirement tasks – support staff in completion, follow up on statuses, and provide updates to other QA and management staff.
- Participate in process improvement implementation teams as a quality representative. Evaluate processes for inefficiencies and opportunities to reduce non-value added tasks, increase user-friendliness, “engineer the human error out” and reduce the costs of poor quality.
- Interact in a collaborative manner with other team members to accomplish organization goals, foster continual improvement, provide ideas to improve efficiencies, contribute to positive co-worker relationships, and maintain a high degree of integrity in all aspects of QA activities.
- Additional QA roles will evolve over time, such as customer Protocol / Report QA reviews, metrics, QA reviews of the core Quality System programs such as change controls, validation protocols, etc.
- Bachelor’s degree or higher in chemistry or a related scientific field.
- Must have a strong attention to detail and excellent communication skills.
- Must be highly proficient in Microsoft Word and Excel.
- Must have a demonstrated professional demeanor and willingness to work positively within a team environment.
- Very strong, demonstrated writing skills are required, such as an ability to write procedures for execution and/or other technical documents for a broad range of audiences and purposes.
- Work with a passion for quality and take initiative to continually improve while maintaining positivity through challenges.
- Analytical chemistry knowledge is a plus.
- Flexible and willing to accept a change in priorities as necessary.
- Ability to effectively manage time while working on multiple assignments.
- Preferred: 1+ years of hands on experience in a QC/QA roll in a cGMP or relevant ISO controlled laboratory environment.
- Application must include a cover letter, resume, and three professional references, including your most recent employer and supervisor (we will not contact him/her until you give permission).
- Final candidate(s) education will be verified and will be required to pass a criminal background check.
- Due to the volume of applications received, we regret that we will not be able to contact every applicant. After screening applications, we will be in touch with those that meet our qualifications and requirement to schedule a phone interview.