Clinical Label Coordinator - Somerset, United Kingdom - TribePost

TribePost

Verified Company

Somerset, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Our Company

BAP Pharma is the fastest-growing, independently owned pharmaceutical clinical trials supply organisation, with specialist divisions in Comparator Sourcing, Secondary Packaging & Labelling and Global Storage & Distribution.

Our story is one of incredible growth and success, which has culminated in receiving many prestigious awards, such as recognition in Diversity & Inclusion and Social & Environmental, and the continued expansion of our core business operations in UK, Germany and the USA.

Our extraordinary growth and success have enabled investment and expansion of our Secondary Packaging and Labelling division into the USA and 2023 will see the relocation of our US operations to a new state-of-the-art 25,000 sq.

ft facility in Somerset, New Jersey - heralding the continuation of our company's mass expansion and growth.

We are now looking for highly qualified, experienced and passionate professionals who are dedicated to providing unparalleled customer service, to continue to drive our business forward and become a part of our success story.

The Role:

This position is responsible for designing, preparing, and coordinating clinical study labels ensuring compliance with regulatory GMP and SOP guidelines.

This role is central to the Packaging & Labelling Operational team, working closely with the Business Management team and Customers.

As Clinical Label Coordinator your main responsibilities will include;

Identification and interpretation of our customers' clinical labelling requirements, ensuring compliance with clinical study and regulatory guidelines.
Review and interpretation of the clinical study protocol, and coordination with Project Management and Operations teams for customized label design and printing requirements.
Perform daytoday activities such as label receipt (blank single panel, and vendor printed booklet labels), label design, printing, inspection, release, storage, and destruction. Ensure these processes are compliant to cGMPs, SOPs, FDA, DEA, and OSHA rules and regulations.
Responsible for issuing, staging, and reconciling clinical labels to/from operations.
Supervise daily scheduling activities of clinical labels ensuring work demands are met in a productive, cost effective, and timely manner.
Help conduct audits of the label control area to assure compliance with cGMPs, GDPs, SOPs, and corporate policies & standards. Help monitor investigations, and write deviations, as well as other quality system reports in EQMS, and ensure appropriate corrective actions, and close out.
Lead process improvement teams, revise SOPs, and implement the agreed change as required.

Position Requirements:

To be successful in this role you must have;

High School diploma education or equivalent, at a minimum.
Must be detail oriented and can handle multiple projects.
Experience in the field of secondary packaging labelling for clinical trials.
Knowledge of US cGMP, GDP, Annex 13, EU and FDA regulations desirable
Ability to effectively prioritize and execute tasks in a highpressure environment is crucial.
Able to easily deal with changing priorities, demands and timelines through analytical and problemsolving capabilities.
Strong communication skills, both written and verbal.
Experience in Label Design, Label Printing and using electronic labelling system is preferrable.

Work Conditions: