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Job Title:

Technical Operations Specialist

Department/Group:

Quality

Location:

Philadelphia

Reports to:

Quality Supervisor Technical Operations

FLSA Status:

Exempt

Summary of Objective:

The Technical Operations Specialist is responsible for performing release testing on finished good products generated by PCI. The Technical Operations Specialist will be responsible for testing, documenting and ensuring the product meets the predetermined specifications as outlined in the appropriate documents. The position will also be responsible for interacting with multiple departments to ensure the testing is conducted as required.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Ability to understand and execute all aspects of the activities performed in Quality Technical Operations Department.

• Maintaining release testing records and procedures in compliance with the company’s Quality Management System and any applicable federal, state, or regulatory requirements.

• Record inspection results and act on material disposition in accordance with approved company processes and procedures.

• Accurately process all material transactions and ensure accuracy throughout the release process.

• Must be an effective team player who actively participates and cooperates with others to improve the overall quality of our processes.

• Represents Quality on assigned project teams and leads those projects relevant to Quality to conclusion.

• Proactively follows up internally to secure missing documentation in order to ensure that all Quality expectations and parameters have been met and to expedite testing of the material.

• Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives.

• Interacting with customers in order to answer Quality related questions in a professional and courteous manner.

• Ability to follow company established Standard Operating Procedures

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor.

SUPERVISORY RESPONSIBILITIES:

No Supervising of employees.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Ability to sit or stand for long periods of time.

• Ability to perform repetitious testing.

• Mechanical aptitude to set up functional testing equipment.

• Ability to perform system suitability testing and to be able to troubleshoot the equipment as necessary.

• Detailed oriented

• Ability to function with minimum supervision.

• Must be able to lift up to 25 lbs.

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled