Data Integrity Compliance Coordinator
Data Integrity Compliance Coordinator
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1 Vacancy
Job Description
Work Schedule
First Shift (Days)Environmental Conditions
OfficeJob 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:
Bachelors 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 100000 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!
Required Experience:
IC
Employment Type
Full-Time
