1+ months

Operations Specialist

Kelly Services
Lansdale, PA 19446
Kelly OCG is hiring for one of the largest Pharma clients in the world. This opportunity is full time and you would be dedicated to work directly with our client with no expected end date. This position offers an enhanced benefit package including PTO, insurance options and paid holidays followed by the client! If you are looking for a career and not just another position, this is a great opportunity for your career goals!

**Operations Specialist**

Responsible for independently coordinating all activities associated with timely packaging, labeling and assembly of clinical materials for designated domestic and international studies in accordance with applicable safety and regulatory requirements as well as company policies. This individual is responsible for timely execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress and review of documentation and procedures.

**Selected Responsibilities:**

+ Use of SAP system to translate clinical trial packaging and labeling designs into electronic pharmaceutical production records

+ Interacts with Project Managers, Planners, Packaging Supervisors and Quality Assurance for the creation, review and approvals of labeling and packaging documentation.

+ Contributing to or authoring SOPs.

+ Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies packaging and participates in adjustment of logistics pertaining to drug supply.

+ Investigate and document deviations to SOPs or GMPs.

+ Monitor and report progress of clinical packaging events at internal and external packaging facilities.

**Additional Responsibilities:**

+ Adhere to dress code policy

+ Request creation and changes of Material Masters (correct plant site)

+ Submit packaging execution (PE) data for Material Master requests

+ Operationalize documents detailing protocol level packaging and labeling strategy for clinical supplies

+ Prepare executable Bill of Materials, Master Recipes, and Production Versions. Create alternate bill of materials as needed

+ Manage Process Orders

+ Manage Re-Packaging and R.E.D. Extension

+ Complete GMP documentation

+ Report potential quality events, non-conformance to GMPs/SOPs when observed

+ Originate a NOE/Author investigations. Define and manage CAPAs.

+ Generate Change Control/Change Management records.

+ Request scopes of work

+ Quote submission for Purchase Order

+ Enter and maintain timelines in database

+ Update of vendor database with actuals

+ Sending batch records

**Education and Work Experience Requirements:**

+ Level 1: Must have 2 years experience in the pharmaceutical industry in a clinical supply related area within operations.

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Posted: 2020-04-10 Expires: 2020-06-11

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Operations Specialist

Kelly Services
Lansdale, PA 19446

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