Sr. CTS Packaging and Labeling Specialist HYBRID Position Available In Montgomery, Pennsylvania

Kelly Services is currently seeking for a Sr. CTS Packaging and Labeling Specialist – HYBRID for one of our top clients in King of Prussia, PA.

JOB TITLE

Sr. CTS Packaging and Labeling Specialist –

HYBRID INDUSTRY

Biotechnology

LOCATION

King of Prussia, PA

DURATION

6 Months (Temporary / Contract) – Potential for extension or conversion to full-time based on performance & operational need.

PAY RATE

$45 – $48 per hour W2 – Depending on experience

JOB DESCRIPTION

The Senior CTS Packaging & Labeling Specialist will support the Clinical Trial Supplies (CTS) team in coordinating packaging and labeling activities for clinical trial materials. This operational role involves collaboration with global teams, vendors, and regulatory bodies to ensure timely and compliant delivery of clinical supplies.

• Application for material numbers for the packaging of clinical trial material and maintenance of material master data.
• Consultation of the global CTS study teams in the development of the packaging design of the studies as an expert for clinical trial packaging.
• Creation and maintenance of packaging plans taking clinical demand into account.
• Management of the inventory of all packaging components required in clinical studies.
• Ordering of materials considering delivery schedules.
• Creation of packaging orders in SAP and coordination of timely processes up to release with global departments.
• Application for and processing of kit lists required for the unique identification of each trial material container (e.g., bottle).
• Coordination of the global provision of samples for release testing after packaging.
• Ensuring that retention samples are taken from each packaging order and stored or later destroyed in accordance with regulatory requirements.
• Initiation and coordination of packaging reworks and relabeling (e.g., with new expiry date).
• Creation and maintenance of status reports on the packaging of clinical trial material.
• Creation of a study-specific label text template for all packaging units.
• Provision of translated and regulatory-compliant label texts for all clinical studies for submission to the authorities of the participating countries.
• Coordination of label printing with internal or external departments or service providers.
• Consultation of the global CTS study teams regarding the development of the label design.
• Collaboration with external service providers in maintaining a specific database for label text translations and regulatory requirements regarding label content.
• Support of other global departments (e.g., Global Commercial Development / Medical Affairs Organization) regarding the packaging and shipping of clinical trial material for IITs.
• Consultation of global departments regarding packaging design and delivery concept.
• Coordination with departments and service providers for the provision of translated label texts, printed labels, and other required packaging materials.
• Creation of packaging orders and ensuring timely delivery.
• Development, review, or revision of SOPs, forms, and templates related to the packaging and labeling of clinical trial material.
• Processing of Global Change Control requests
• Participation in the preparation of audits and inspections regarding trial material-related topics
• Processing of findings from audits and inspections
• Leading meetings with global CTS study teams to define the packaging and labeling strategy.
• Leading or participating in meetings with external service providers regarding packaging and labeling issues.
• Participation in global study team meetings and CTS meetings.
• Occasional travel to vendors (e.

g., Allentown, PA; Chicago, IL) and potentially to Germany.

Qualifications:

– Bachelor’s degree required (life sciences or business preferred). – 2+ years of experience in clinical research, clinical supply, or pharma operations. – Knowledge of ICH-GCP, cGMP, and clinical study regulatory environment. – SAP experience preferred. – Ability to work independently and across global time zones. – Strong communication and collaboration skills. Why Kelly? Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests. As a Kelly Services employee, you will have access to numerous perks, including: Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group-rate insurance options available immediately upon hire

• Let us help advance your career today .

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