Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Bohemia, NY / Clinical Trials Division - The Clinical Trials Division is one of the five divisions that make up the Pharma Services Group. We specialize in the facilitation of the clinical trial stage of drug development. This allows us to serve the needs of Small/Emerging, Mid-Sized, and Large Pharma sectors globally.

Work Schedule : 1st shift Monday through Friday 8:00 AM to 4:30 pm.

Discover Impactful Work:

Daily execution of product batch documentation archival scanning and processing of actions in eDMS (electronic document management system).

A Day in the Life:

Supports the completion of batch records, memos to file, and other batch record associated documentation.

Coordinate the storage and retrieval of all batch records from the batch record archives.

Maintains current database records related to batch record review, storage, and archival.

Supports routine archiving as well as the destruction of outdated archived batch records.

Maintains storage for all documents associated with batch records and generates approved record copies for clients when requested.

Provides backup with Trackwise by supervising Complaints, Quality Investigations, CAPA, and Deviations daily.

Documents trends related to Error Classification, Root Causes, reoccurrence, turnaround (cycle) time, total opened and closed records, and any outstanding records.

Organizes Standard Operations Procedures (SOP’s), Work Instructions (WI’s) and Forms.

Collects and analyzes quality data, runs Trackwise queries for information, and prepares and distributes applicable quality reports.

Manages and completes all new or updated documentation from date stamped to filing.

Creates and revises all QA documentation and Pack-Out procedures and work instructions.

Plans, performs and coordinates the following QA projects to ensure all quality results are met:

Outdated batch record disposition

Log book creation, issuance, retrieval, review and archival

Biennial Master Documentation (SOP’s, Manuals, WI’s)

Interprets Quality Assurance standards by outlining the department policies and procedures.

Supports training for new colleagues in QA Documentation and Pack-Out.

Involved in investigation support. Fact-finding, interviews, document review and gap assessments.

Involved in Audit hosting. Facility tours, document retrieval and upload, question responses and discussions.

Involved in Audit responses. Drafting response CAPAs and observation reports.

Assist Pack Out and QA Final Release on a regular basis.

Other duties may be assigned to meet business needs.

Frequent Contacts:

Internal

All local personnel.External

Collaborate with other ThermoFisher sites on projects and/or identifying best practices.

May be required to contact off site data storage

Keys to Success:

Education

Associates or Bachelors degree required.Experience

2+ years of related experience in cGMP and/or QA required

Experience in a GMP environment preferred, equivalent experience accepted in lieu of degree.

Knowledge, Skills, Abilities

Proficiency with computer skills, specifically Microsoft office applications, with the ability to learn new computer systems quickly (Excel, Word, Power Point)

Ability to use software and customized programs to meet business needs; Effective written and verbal communication skills; Good organization, planning, multi-tasking, and time management skills.

Physical Requirements / Work Environment

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 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.

Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment

Compensation and Benefits

The hourly pay range estimated for this position based in New York is $21.00–$26.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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.