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Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

POSITION SUMMARY

The Data Integrity Compliance Coordinator ensures compliance with data integrity standards at the pharmaceutical manufacturing site by providing administrative and operational support within the Quality Assurance (QA) department. The role focuses on driving and tracking activities related to regulatory requirements, particularly 21 CFR Part 11 and EU Annex 11, within laboratory and manufacturing systems. This position is essential for maintaining a culture of compliance with FDA, EMA, and other global health authority expectations related to GMP, GDP, and electronic record/data integrity. It is designed for a highly organized individual who excels in documentation, scheduling, compliance tracking, and cross-functional coordination. **Typical hours are Monday - Friday, 8:00am - 5:00pm.**

Key Responsibilities:

+ Responsible for Governance Meeting Coordination and will organize, schedule, and prepare materials for the Data Integrity Site Governance Team. Record and distribute meeting minutes and action item trackers.

+ Organize and structure data integrity metrics and performance indicators with the help of tools such as TrackWise, Power BI, and internal audit records. Maintain accuracy and timeliness of metric dashboards submitted to global QA.

+ Assist in tracking system remediation activities for equipment and instruments to ensure compliance with 21 CFR Part 11 and Annex 11.

+ Provide administrative support for ongoing DI remediation projects and continuous improvement initiatives. Maintain and follow up on project timelines and task completion status.

+ Assist in the scheduling, tracking, and documentation of DI awareness training.

+ Support development of basic training materials or visual job aids.

+ Draft, revise, and route controlled documents (e.g., SOPs, forms, work instructions) related to Data Integrity programs. Track revisions and ensure compliance with document control procedures.

+ Help schedule and coordinate Data Integrity walkthroughs and audits in GMP areas (QC labs, manufacturing suites). Document and track surveillance findings and corrective actions.

+ Support the oversight and approval of DI-related deviations, CAPAs, and change controls for QA review. Track status and timelines using the electronic quality system (e.g., TrackWise).

+ Coordinate logistics for data integrity risk assessments including scheduling, material preparation, and documentation.

+ Assist in assembling monthly DI metric presentations for site leadership meetings.

+ Focused on administrative and operational execution of Data Integrity program activities.

+ Works with QC laboratories, manufacturing, QA, IT, and validation teams.

+ Ensures tasks and documentation are aligned with GMP, GDP, and DI expectations from global health authorities.

+ Helps maintain a state of inspection readiness for all paper-based and electronic data systems.

Qualifications:

+ Bachelor’s Degree required, in a scientific, pharmaceutical, engineering, or related field preferred.

+ 2+ years of experience in the pharmaceutical or biopharmaceutical industry within a GMP-regulated environment required.

+ Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, Administrative or quality support roles with exposure to laboratory instrumentation or manufacturing data systems preferred.

+ Experience with quality systems such as TrackWise is highly desirable.

+ Familiarity with 21 CFR Part 11, Annex 11, and other data integrity guidance is essential.

+ Experience supporting QA documentation and training coordination is a plus.

+ Solid understanding of cGMP and cGDP in a pharmaceutical setting.

+ Solid understanding of 21 CFR Part 11 / Annex 11 compliance principles as well as Data Integrity related regulations and guidance documents.

+ Strong organizational and documentation skills.

+ Proficient in Microsoft Office Suite (especially Excel and PowerPoint).

+ Excellent communication and interpersonal skills.

+ Ability to handle multiple tasks and meet strict deadlines with minimal supervision.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

What We Offer

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

Compensation

+ Competitive Pay

+ Annual performance-based bonus

+ Annual merit performance-based increase

Excellent Benefits

+ Benefits & Total Rewards | Thermo Fisher Scientific

+ Medical, Dental, & Vision benefits-effective Day 1

+ Paid Time Off & Designated Paid Holidays

+ 401K

+ Tuition Reimbursement

+ Employee Referral Bonus

+ Career Advancement Opportunities

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.