QA Assistant Temp.

This is a temporary opportunity expected to last up to 6 months.

About the role

The Quality Assurance (QA) Assistant is an entry-level trainee position. The QA Assistant will perform audits of incoming and in-process materials, process documentation, and labeling to assure accuracy and compliance with Good Manufacturing Practice (GMP) Regulations and Standard Operating Procedures (SOP).

The working hours for this role are Mon-Fri 8:30am-5:00pm.

Responsibilities

Under the training, mentorship, and review of senior Quality Assurance personnel, learn and apply the principles of GMP compliance to work assignments including:

• Provide administrative assistance and support of Quality Assurance (QA) as needed.
• Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with applicable GMPs and Standard Operating Procedures.
• Review incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures.
• Review accessory product records for compliance with the requirements detailed in product specifications and applicable testing procedures.
• Review instrument release packages for compliance with the requirements detailed in product specifications and applicable testing procedures.
• Utilize company-provided software to monitor and release materials.
• Perform all other related duties as assigned.

Requirements

• Associate’s degree (A.S./A.A.) or equivalent, preferably in a life science or related discipline.
• Entry-level – 0+ years of experience.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Knowledge of Microsoft Office® applications and spreadsheet programs such as Access and Excel.
• Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements.
• Effective written and oral communication skills.

Pay

$21.00 per hour. Salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Microbial Solutions

Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection, and microbial identification products and services, designed to meet the complex and ever-changing needs of the industry. We help clients ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision-making, and improve operational efficiencies.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities.

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our clients’ unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies, hospitals, and academic institutions worldwide. In 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, excellent science, and strong sense of purpose guide us in all that we do. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.