Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Join Thermo Fisher Scientific to contribute globally, making a positive impact daily.
Location/Division Specific Information:
Marietta Manufacturing site is in the Laboratory Products Division, providing equipment for pharmaceutical and biotechnology research.
How Will You Make an Impact?:
In this role, you will play a crucial part in ensuring flawless documentation practices, which are essential for maintaining our world-class standards. Your meticulous attention to detail will help us strictly adhere to regulatory requirements and successfully implement continuous improvement initiatives.
You will ensure that all documents are accurate, up-to-date, and aligned with industry standards and regulations, reducing the risk of non-compliance issues.
You will improve communication and collaboration across departments by providing easy access to accurate and consistent documentation.
By implementing efficient document control processes and systems, you will help streamline workflows, reduce redundancies, and improve overall efficiency.
By managing project documentation effectively, you will support project managers in meeting deadlines and achieving project goals
A Day in the Life:
Review DHR's for Good Documentation Practice and Good Manufacturing Practice.
Inspect, measure, and report Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) performance of reviewed records.
File records (electronic or hard copy) in designated locations, retrieve as necessary to support the business.
Perform and record inspections / acceptance, control, and release of manuals.
Identify, error-check, log, and file documents critical to GMP compliance.
Assist in the creation, revision, and formatting of standard operating procedures (SOPs), work instructions, and other controlled documents.
Lead change control processes, ensuring that all document changes are accurately reviewed, approved, and implemented.
Handle the retention and archiving of documents in accordance with company policies and regulatory requirements.
Participate in continuous improvement initiatives to improve document control processes and systems.
Stay updated with regulatory requirements and industry standards to ensure ongoing compliance.
Work closely with other departments, such as Quality Assurance, Manufacturing, and Supervisor/Managers, to ensure document control processes align with their needs.
Monitor and report on critical metrics linked to document control activities.
Education:
High school diploma or equivalent experience required.
Experience:
Required: Minimum of 1 year of work experience in QA or QC or related field
Preferred: Experience in a cGMP environment
Knowledge, Skills, Abilities:
SAP experience, desired
Strong attention to detail
Written and verbal communication skills
Experience with Microsoft Office
Physical Requirements / Work Environment
Ability to lift up to 35 lbs unassisted, unpackage / repackage materials
What We Offer
Compensation
Competitive Hourly Pay Rate
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
Retirement Savings Plan
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities
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.
Accessibility/Disability Access
Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations during the application process. This includes help for hearing, vision, mobility, or cognitive challenges.
Dedicated telephone line for job seekers with disabilities needing application process accommodations.