QA Associate

Overview

Job Title:

QA Associate I;
Effective Date: 12/02/2024

Department:
Quality |

Reports to:

QA Supervisor

The role of the QA Associate is to provide support to our customers, quality management system programs and the entire manufacturing operation to meet all requirements. This position plays a vital role in helping our company achieve success through quality monitoring, control, modification, and continuous improvement.

• 401(k) matching
• Dental insurance
• Employee discounts
• Health insurance
• Paid time off
• Vision insurance

• Perform incoming raw material and packaging inspection, sampling and release activities.
• Perform batch record issuance, review, and product release and disposition activities.
• Conduct QA on the floor duties including but not limited to real time documentation and in-process reviews.
• Daily temperature monitoring and recording.
• Issue and review logbooks for GMP compliance.
• Review quality documentation including specifications, manufacturing batch records and SOPs to ensure compliance and revise as needed to maintain a state of compliance.
• Support activities related to qualification and validation of equipment and processes.
• Assist in maintaining document control files (filling documentation in the Archive Room).
• Oversight in maintaining retain samples.
• Assists with stability sample pulls and stability reports.
• Control and issuance of labels and inserts.
• Maintenance and cleaning of sampling room.
• Represent QA on various projects and support activities associated with manufacturing, testing and release of products.
• The list of responsibilities assigned to this position is not necessarily all inclusive and will change as needed to meet organizational needs.

• High school diploma required; bachelor’s degree (business, engineering or science related field preferred) preferred.
• 1-2+ years applicable experience in pharmaceutical or medical device industry.
• Effective written and oral communication skills; ability to write, type, and effectively communicate information and instructions accurately.
• General knowledge of quality system elements and cGMP regulations.
• Flexibility to work occasional weekends and evenings.
• Attention to detail in review of GMP records e.g., batch records, specifications, analytical data, CoA, etc.
• Computer familiarity (Microsoft Office Word and Excel) and record keeping skills.
• Ability to follow Standard Operating Procedures and accurately complete paperwork.
• Demonstrated ability to work in a team environment comfortably and effectively.
• Good interpersonal skills, adapt readily to change, manage multiple priorities.
• Must be well organized and very detail oriented.