At least 3 years
Job Description
The Data Integrity Specialist supports research laboratory and manufacturing operations by assessing and enhancing compliance with data integrity requirements. This role focuses on understanding data life cycles, identifying compliance gaps, conducting periodic system reviews, and partnering with laboratory and manufacturing teams to implement robust procedures, documentation, and training that strengthen overall site compliance.
Responsibilities
- Research laboratory and manufacturing processes to develop comprehensive compliance gap assessments related to data integrity.
- Analyze and understand laboratory and manufacturing data life cycles to develop detailed data maps.
- Report regularly on the progress of data integrity initiatives and clearly communicate the significance of findings and results.
- Complete Periodic System Reviews according to schedule, working closely with system administrators and subject matter experts to accurately assess systems and associated data.
- Assess risks related to data integrity and collaborate with colleagues to develop, implement, and monitor appropriate corrective and preventive actions.
- Assist laboratory and manufacturing personnel in developing procedures, job aids, and other documentation to improve overall site compliance.
- Perform data integrity training using approved course curricula for laboratory and manufacturing personnel.
- Utilize expertise in data integrity to provide guidance and support on compliance issues in both manufacturing and laboratory environments.
- Review and author standard operating procedures to ensure they align with applicable regulations and data integrity expectations.
- Apply cGMP, GLP, or GCP regulations within manufacturing and laboratory environments with a specific focus on data integrity requirements.
- Participate in quality assurance activities, including batch record review, CAPA processes, and audit support related to data integrity.
- Collaborate with cross-functional teams to promote a strong quality and compliance culture throughout the site.
- Bachelor’s degree in a relevant scientific or technical discipline is preferred, or equivalent work experience.
- Three or more years of relevant work experience interpreting and applying cGMP, GLP, or GCP regulations, with a focus on data integrity requirements.
- Strong understanding of data integrity principles and their application in both manufacturing and laboratory environments.
- Experience reviewing and authoring standard operating procedures.
- Proficiency with core computer software and systems, including Microsoft Word, Excel, SharePoint, and Project.
- Knowledge of quality assurance practices, including CAPA, batch record review, and audit support.
- Familiarity with FDA expectations and regulatory requirements in a pharmaceutical or related regulated environment.
- Ability to communicate complex regulatory and data integrity concepts clearly to diverse stakeholders.
- Strong attention to detail and ability to maintain accuracy in documentation and data review.
- Ability to work effectively in a team-based environment and collaborate with laboratory, manufacturing, and quality personnel.
- Experience working in a GMP pharmaceutical or similar highly regulated environment.
- Background in quality assurance, including exposure to audits and regulatory inspections.
- Experience with batch record review and documentation control processes.
- Ability to design and deliver training on data integrity and compliance topics.
- Strong problem-solving skills with the ability to assess risk and recommend practical corrective and preventive actions.
- Comfort working with electronic systems and databases used in laboratory and manufacturing settings.
- Ability to manage multiple priorities and meet scheduled deadlines for periodic reviews and compliance activities.
- Strong written and verbal communication skills suitable for reports, procedures, and training materials.
This is a full-time role with a standard schedule of Monday through Friday, 8:00 a.m. to 4:30 p.m. A hybrid work schedule may be available after initial training, with the potential to work 1–2 days per week from home, depending on business needs. The position is based in a plant that produces radioactive materials and requires participation in comprehensive safety programs designed to minimize potential and actual exposure levels. The role involves both office and plant-floor activities and may require lifting up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reaching. You must be able to negotiate stairs and evacuation ladders, enter vessels, and inspect equipment, with or without reasonable accommodation. Material handling devices such as hand trucks, fork trucks, and conveyors are used when possible, but proper manual lifting and movement techniques remain essential. You must be willing to wear a variety of Personal Protective Equipment (PPE), including hearing protection, as needed. The position may require sitting or standing for extended periods of 8 or more hours per day and demands good hand–eye coordination and close attention to detail. Work occurs both indoors and outdoors with exposure to mechanical and moving parts, as well as potential hazards including corrosive, flammable, and toxic materials, dust, dirt, odors, and irritants. You must complete all required safety training within designated timeframes and work effectively in a team-based environment. Flexibility to work outside regular hours, including off-shift, weekend, and holiday work, may be required based on business needs. The organization offers a long-term contract opportunity with the potential for extension, along with paid holidays and paid time off, within a culture that emphasizes safety, regulatory compliance, and collaborative teamwork.
Job Type & Location
This is a Contract to Hire position based out of Maryland Heights, MO.
Pay and BenefitsThe pay range for this position is $32.00 - $37.13/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)
This is a hybrid position in Maryland Heights,MO.
Application DeadlineThis position is anticipated to close on May 29, 2026.
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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006028065
