Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Title: Quality Specialist III

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.

Division/Site Specific Information
Role based at the Allentown, PA site, and will support the Clinical Trails Division (CTD) at Thermo Fisher Scientific.
 

Discover Impactful Work:

The Quality Specialist III makes an impact by adhering to the fundamentals of cGMP with a focus on patient safety and supports the rapid launch of products. Uses sound knowledge of regulations, authorizations, products, and processes, coupled with the experience of manufacturing and packaging, and its business requirements to thoroughly verify all aspects of the batch safety, identity, strength, purity, and quality. Collaborates with Clients to fully comprehend their Batch review and release requirements and the regulatory obligations which their company must fulfill.

A Day in the Life:

Carries out a full analysis of all inputs into the Batch creation process. Considers all factors that may affect the quality of the batch in view, such as environmental monitoring, analytical results, calibration, validation, preventative maintenance records, and investigations to include the impact of ‘split-site’ or ‘multiple-site’ processing as part of the final batch release criterion.

Ensures product batches that have not met the prescribed in-process and finished product specifications and regulatory requirements are dispositioned to be quarantined or rejected (when applicable) to prohibit use or release.

Interacts with Operations, Quality (QA), and internal functional units for resolution of batch release quality issues or potential quality issues.

Proactively identifies batch review concerns, promptly communicates and raises (when appropriate) issues of batch release non-compliance, Out-of-Specification (OOS), or potential failure to Quality Management. Recommends steps to resolution, when appropriate.

Prioritizes batch record reviews and Client releases to achieve objectives and deliver industry quality results within a short and long-term operational focus with mentorship from the Production Schedule, Client Services, and Quality Management.

Maintains both internal and external customer service expectations with clear, concise, and expedited communication.

Communicates delays promptly to affected internal parties.

Ensures the above-mentioned provisions, to include the cumulative processing impact are analyzed, and are satisfied before the finished goods batch is certified to be placed on the market.

Represents QA and provides support to internal team meetings, as needed.

Initiates and updates SOPs, as the need arises.

Trains and mentors junior staff on interdepartmental processes and in activities critical to the success of departmental and verification compliance.

Reflects the level of batch review compliance innovation to develop new insights, methods, techniques, and services.

Employs metrics to track the performance of Batch Record/Release Operations and Compliance.

Keys to Success: Education

Bachelor’s Degree required (degree in Life Sciences, preferred). Master’s Degree preferred.

Experience

3-5 years' experience of working pharmaceutical or medical device experience in a GMP environment, preferably in Quality.

3 years' experience of finished goods commercial batch record release experience strongly preferred.

Experience with Quality Systems (change control, deviations, complaint management, eDMS), with a desired knowledge of SAP, Trackwise and Documentum.

Knowledge, Skills, Abilities

Proven understanding of cGMP regulatory requirements such as FDA, EU MHRA, ICH, USP, EU, and a knowledge of manufacturing quality and its impact to product safety, identity, strength, and purity

Strong problem solver that uses effective approaches for choosing a course of action or developing effective and sound solutions to identify and prevent quality issues.

Proven initiative and demonstrated accountability in a fast-paced environment with a high degree of flexibility and willing to take action that is consistent with available facts, constraints, and probable consequences.

Must be detail-minded detecting errors or deficiencies on batch records with the ability to use good judgment in discerning if documentation accurately and completely reflects packaging operations.

Ability to communicate openly and effectively in an engaging manner with colleagues of various levels of experience and management.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, 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.