QA Associate

Benefits

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

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.

• 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.
• 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.