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Description

+ Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

+ Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).

+ Independently conducts, completes, and documents major and minor deviation investigations related to GxP operations.

+ Conducts, completes, and documents critical deviations with assistance from management and/or more high level investigators.

+ Participates in cross-functional meetings with internal and external parties as required.

+ Apply Root Cause Analysis tools to identify root causes and propose effective corrective and preventive actions.

+ Supports management and tracking of quality system records (i.e., Deviation Reports, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.

+ Responsible for maintaining tracking tools/databases.

+ Responsible for sending periodic reminder notifications to leads/coordinators.

+ Supports management review process through development and generation of quality system metrics and trending, and escalate issues as required. Perform additional logistics support for management review process.

+ Supports the maintenance and improvement to quality systems processes, as needed

+ Works directly with operating entities and internal clients with assistance from management and/or more high level investigators to ensure follow-up of quality issues.

+ Participate in the development of training programs regarding all aspects of producing quality products, as required.

+ May assist compliance audits as required.

+ Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.

+ Provides guidance and technical knowledge for junior staff as required.

Additional Skills & Qualifications

Knowledge & Skills

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.

• Demonstrates knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution, and maintenance.

• Demonstrates knowledge of Six Sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.

• Demonstrates investigation skills and report writing skills.

• Demonstrates strong verbal, technical writing, and interpersonal skills.

• Demonstrates proficiency in Microsoft Office applications.

Education & Experience

• 5+ years of relevant experience in a GMP environment related field and a BS or BA.

• 3+ years of relevant experience and a MS.

• Prior experience in pharmaceutical industry is preferred.

Job Type & Location

This is a Contract position based out of Parsippany-Troy Hills, NJ.

Pay and Benefits

The pay range for this position is $40.00 - $45.00/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 hybrid position in Parsippany-Troy Hills,NJ.

Application Deadline

This position is anticipated to close on Dec 9, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.