Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

How will you make an impact:  

Provide support for Lab Operations (LO) activities such as generating, reviewing and revising specifications for Finished Products, intermediates and Raw Materials (RM) and stability protocols. Support with Certificates of Analysis (CofAs) issuance for In-Process, Raw Material, Bulk and Finished Product. Support with Vendor change assessments, material gap analysis, compendial update assessments, Residual Solvent and Elemental impurity assessments. 

 

What will you do?   

Training Record Management

Support and maintain training records for Lab OperationsManage SuccessFactors Learning Management System (SFLMS) activities for Lab OperationsAct as the Department lead and troubleshoots for SFLMS issues and provides support to end usersEnsure Lab Operations aligns with SFLMS requirementsProvide ongoing training and expertise to department usersDevelop Work Instruction (WI) related to Standard Operating Procedures (SOPs) or SFLMS as neededTrain the designated Lab Administrator to assist on SuccessFactors and Documentum admin work.

ARF/Specification/CofAs/Compendial Updates, Elemental and Residual Solvent risk assessment Management

Generate ARF/CoA based on Quality Record (QR)/Change Control requirements or new parts requests to meet MPS (Manufacturing Production Schedule) and On Time Delivery (OTD) of QRsGenerate and revise Specifications/eCoAs per SharePoint requestsAddress client comments regarding ARFs/CoAsReview, update and maintain ARF index databaseSupport Annual product review (APR) (as needed)Support indexing, filing and archival of obsoleted ArtworksSupport Gvault activitiesSupport Compendial updatesSupport SampleManager activities

Data Package Management

Prepare and create data package per Lab Operations requests by collecting data and informationWork with lab and reviewer groups to addresses data package related client commentsMaintain a safe working environment and report potential hazards.Perform alternating or rotating shift work (as required)

How will you get here:

Education:
Bachelor of Science in chemistry, biology, pharmacy, or other related field
Experience:

Previous experience in a science related environment.
Minimum 2 years of working experience as Lab Administrator or equivalent.

Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Computer proficiency with Microsoft Office programs (e.g., Outlook, Excel, Word). Excellent interpersonal skills (verbal and written). Ability to multi-task. Detail Oriented and reliable. Works well independently and in a team environment. Proficiency with the English language.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, 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