Job Title: Quality Assurance Associate

Job Description

We are seeking a Quality Assurance Associate to support on-the-floor QA issues within the manufacturing suite. This role requires mitigating gaps and risks for all quality and GMP processes, running investigations for deviations, change controls, CAPAs, and out-of-specifications, as well as reviewing and authoring SOPs.

Responsibilities

• Support on-the-floor QA issues within the manufacturing suite.
• Mitigate gaps and risks for all quality and GMP processes.
• Run investigations for deviations, change controls, CAPAs, and out-of-specifications.
• Review and author SOPs.

Essential Skills

• Quality assurance experience
• Document control
• Batch record review
• CAPA management
• Deviation handling
• Compliance with audits and quality systems management

Additional Skills & Qualifications

• BS degree with 3-5 years of experience
• Experience supervising or managing direct reports
• Support for GMP requirements and compliance
• Knowledge of cGMP, FDA regulations (21 CFR Parts 211, 212), and ICH guidelines

Work Environment

You will work with a team of 3-4 individuals in a 1st shift Monday to Friday business casual environment. Occasional weekend work may be required. The company values hard-working individuals and great team players. Benefits include participation in all company events, access to fully stocked kitchens with snacks and beverages, company-provided lunch twice a week, and access to an on-site gym that is open 24/7.

If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com.

Pay and Benefits

The pay range for this position is $25.00 - $27.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Waltham,MA.

Application Deadline

This position is anticipated to close on Mar 21, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $25 - $27