QC Scientist II

ThermoFisher Scientific

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 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, ensuring our food is safe, or helping find cures for cancer.

A Day in the Life:

Lab Testing

Conducts moderately complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.

Perform analyses in a chemistry or microbiological environment within defined procedures and practices.

Prepare documentation of the testing/analysis and obtained results.

Document, calculate, verify, approves and/or report results of the analysis in accordance with prescribed lab procedures and systems.

Support and/or coordinate sample analysis and maintain a schedule plan to ensure goals and objectives are met within the prescribed time frame.

Regulatory

Perform analysis report of regulatory data (Compendial Changes, Annual Product Review, Equipment assessment, regulatory audits responses, etc…) to identify trends and recommend updates or changes to quality standards and procedures when necessary.

Evaluate, create, review, and approve specifications, methods, protocols, procedures and risk assessment for compliance with current regulations (i.e., GLP, cGMP, global regulatory requirements, company policies and other applicable regulations and guidelines).

Support the complete lifecycle of sample management during a stability study which includes, but is not limited to stability sets, pulls, aliquoting, shipments, disposal, and supporting LIMS and/or paper GMP documentation at each of those steps per site SOPs.

Coordinate and organize communication with multiple departments and clients to provide support or direction in the changes required to complete the process activities.

Documentation

Prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications, investigations, and reports.

Manage and monitor the Change Control and Stability program, Specifications, Methods, and Protocols to ensure that goals and objectives are accomplished within the prescribed time frame.

Facilitate internal training on quality assurance requirements, processes, and procedures.

Other

Evaluate, challenge, and implement quality improvements to processes across PDS, Commercial and Quality operations.

Ensure change controls and stability program are completed in compliance with applicable standards.

Challenge, assess, and assist various departments with the processing of change controls.

Review and/or approve Laboratory data, protocols, and reports for Commercial, Non-Commercial and Stability products.

Develop, review and/or approve product specifications, methods, procedure, and stability studies.

Review and propose revisions to QC procedures and SOPs for better compliance and efficiency in meeting clients’ demands

Provides quality status updates for client activities and products

Receive, pull, coordinate, monitor and/or analyze stability and/or commercial samples for the Laboratory.

Report, verify, and/or approve analytical data

Authority Levels:

Authority to generate and review CAPAs, APR reports, Specifications, Method, Protocols and Stability reports.

Manage the Change Control system and Stability Program.

Functional Guidance:

Assistance is available from the QC Supervisor and QC Managers of Quality Control

Keys to Success:

B.Sc. in Chemistry, Biology, Life Sciences or other related field

2 years of quality or lab related experience

Excellent interpersonal oral and written communication skills

Proficiency in the English language

Available to work on different shifts

Experience with quality system, stability specific laboratory systems and laboratory chromatographic data acquisition systems preferred.

Experience with Microsoft Word and Excel

WORKING CONDITIONS:

Physical Effort:

There is little physical effort and fatigue. Walks, stands, lift small objects (medium weights of 10-35 pounds), tools, operates keyboard equipment, and medium physical effort activity such traveling/driving. Requires 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, latex or similar gloves, safety apron, organic respirator occasionally.

Physical Environment:

Located in a comfortable indoor area. Any unpleasant conditions would be based on the audit to be site for a short duration.

Sensory Attention:

Regular need to attend closely to complex or subtle stimulus that requires great diligence and attention for proper interpretation.

Mental Stress:

There is regular pressure from deadlines, accuracy, or similar demands.

Benefits:

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!

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. We will gladly provide reasonable accommodations covered under the ADA.

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.