• , US

Company:  Confidential

Job Title: QA Associate

Job Number: 62643

Location: , US

Job Description

We are looking for an individual who is self-driven and can work well in a team. This will involve tasks such as scrutinizing batch records, investigating deviations, issuing labels, and managing company-wide controlled documentation, training, and facility support systems, including tracking, distributing, and archiving them in accordance with GLP/GCP/GMP regulations.


* Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices. * Support supplier and material management, including ordering, incoming receipt, and record-keeping. * Coordinate, track, and archive controlled records (i.e., batch/test records, logbooks, validation documents, labels, reports, forms, etc.) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance. * Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system. * Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports. * Collaborate on the development/improvement and implementation of material, facility, and quality management systems. * Support clinical product manufacturing by reviewing batch records, printing labels, packaging products, and coordinating shipping. * Manage inventory databases, ensuring accurate and timely updating of lot numbers and quantities. * Perform other assigned duties as required.

Required Skills

* Bachelor’s Degree and 2+ years of experience in a cGMP environment * Comfortable working in a fast-paced and dynamic environment  * Knowledge of standard processes involved in document control and experience in an FDA regulated environment * Aseptic Processing experience is a plus. Additionally, strong computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems.  * Precise attention to detail and excellent record keeping skills. Familiarity with Quality Systems and records management in a cGMP environment is also important.  * Must have strong communication and problem-solving skills, be results-oriented with dedication to compliance and customer service, and exhibit strong initiative and follow-through. Salary range: $65,000-85,000K annually Benefits: Health Insurance (medical, dental, vision) Life Insurance Short- and Long-Term Disability 401(k) Paid Time Off

Application Deadline: 2023-10-20


Apply for job

To apply for this job please visit jobrxiv.org.