Job Title: Quality Investigator

Job Description

The Senior Biotech Quality Investigator is responsible for conducting thorough investigations of deviations, non-conformances, and other quality-related issues within a GMP environment. The role ensures compliance with regulatory standards and internal procedures, aiming to identify root causes and implement corrective and preventive actions (CAPA). Investigations will be focused on facilities, utilities, and engineering spaces.

Responsibilities

• Conduct thorough investigations of deviations, non-conformances, and other quality-related issues.
• Ensure compliance with regulatory standards and internal procedures.
• Identify root causes of quality issues and implement corrective and preventive actions (CAPA).
• Focus investigations on facilities, utilities, and engineering spaces.
• Document investigations, CAPAs, and other quality-related records with exceptional technical writing skills.

Essential Skills

• Minimum of 5 years of experience in a GMP-regulated environment, with a focus on microbiology, environmental monitoring, engineering controls, and maintenance.
• Minimum of 3 years of proven experience in writing deviations, investigating CAPAs, and closing records.
• Strong understanding of GMP regulations and guidelines.
• Proficiency in technical writing.
• Excellent analytical and problem-solving skills.
• Attention to detail and strong organizational skills.
• Proficient in using quality management software and tools.

Additional Skills & Qualifications

• Bachelor's degree in Microbiology, Biology, Engineering, or a related field.
• Ability to work independently and as part of a team.
• Great communication skills, with the ability to clearly and effectively communicate with SMEs, team members, and stakeholders.
• Strong networking skills to collaborate with Subject Matter Experts (SMEs) across various departments.
• Flexibility to adapt to changing priorities and work in a fast-paced environment.
• Strong critical thinking skills to analyze complex issues and develop effective solutions.

Work Environment

This position is onsite within a biopharma setting. The role involves working with advanced technologies and equipment in a regulated environment. Employees can expect a professional atmosphere where adherence to GMP standards is critical. The company offers 10 days of PTO and 6 holidays per year, contributing to a balanced work-life experience.

Pay and Benefits

The pay range for this position is $60.00 - $76.92/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 Framingham,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 : $60 - $77