Catalent Pharma Solutions, Inc.

Description
Catalent Pharma Solutions is the leading provider of advanced technologies as well as development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer health companies in nearly 100 countries. Our services include Development, Drug Delivery, Manufacturing, and Packaging.

Operations Specialist
The Operations Specialist role will handle a wide range of duties within the operations department including but not limited to the following:

Creating and revising master batch records

Creating and revising operations standard operating procedures

Performing investigations related to problem reports

Writing problem reports

Coordinating some activities related to daily operation

Acting as a coordinator of operations activities.

Specific Duties, Activities, and Responsibilities (% of time)

Manage Problem Reports as they relate to Operations. Includes writing and managing the completion of CAPA’s, Deviations, and Change Controls 10%

Interact with QA and other functional areas to ensure timely closure of designated batch related investigations 10%

Proactively track and monitor status of investigation reports to timely completion. 5%

Compile and maintain metrics related to operations. 5%

Interacts, where required, with customers when input is required into PR content. 5%

Interact with production staff to create Standard Operating procedures for processes, equipment or other as designated. 10%

Revise SOP’s as a result of process improvement, customer requests, audit observations or other. 10%

Interact with other departments and customers to create master batch records. Interaction will be required with QA, tech transfer and operations departments to assure an accurate MBR. 15%

Interact with production personnel on continuous improvement projects related to procedures, batch records or other assignments. 10%

Identifies process deficiencies and recommends corrective improvements. (100%)

Provides training to management and production personnel to promote well-written, thorough investigation reports. 5%

Act as a coordinator for operations activities including JD Edwards support, batch record requisition, work order creation and some production planning activities. 10%

Meet attendance requirements for the job. (100%)

Comply with cGMPs through adherence to SOPs, and company policies relating to quality, safety, housekeeping and cost effectiveness. (100%)

Other duties as specified by the Operations Manager. 5%

Requirements
This applicant MUST have prior work experience in pharmaceutical manufacturing operations.

The Operations Specialist job position requires an individual with active communication skills, strong written and verbal skills, and an ability to work with many different departments to complete investigations or improve processes.

Position Requirements

Education/Experience or Equivalent

Bachelor’s Degree

1-2 years related experience in pharmaceutical manufacturing operations is REQUIRED for consideration.

Knowledge, Skills, and Abilities Requirements

Demonstrate excellent communication skills both written and verbal.

Demonstrate analytical and organizational skills.

Demonstrate excellent technical writing skills.

Demonstrate strong math, calculating and, computer skills.

Demonstrate ability to read, understand, interpret and implement technical writing and instructions.

Demonstrate ability to multi-task and coordinate many areas of the operation simultaneously.

Demonstrate ability to work with a wide range of people to solve problems and resolve issues.

Demonstrate knowledge of aseptic manufacturing processes and procedures.

Work in fast-paced, high-stress, dead-line oriented environment.

Assertive self-starter who will take initiative and is results oriented.

Physical/Mental Requirements

Attention to detail.

Must be able to learn and retain technical information.

Work Environment

Consists of performing duties in a regulated pharmaceutical manufacturing facility.

Primary duties or functional responsibilities are performed in an office environment and controlled areas.