Technical Operations Specialist

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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 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 to answer Quality-related questions professionally and courteously.
• 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 of performing 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.
• 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 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 of performing the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

The noise level in the work environment is usually moderate.

Qualifications : The requirements listed below are representative of the knowledge, skill, and / or ability required for the stated position.

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

High school education or at least (2) years of pharmaceutical, scientific, or pharmaceutical packaging experience.

EDUCATION AND / OR EXPERIENCE :

• Possesses excellent organizational, time management, and multi-tasking skills to meet commitments and deadlines.
• Knowledge of basic product release testing
• Strong problem-solving skills and detail-oriented.
• Basic understanding of cGMP requirements and AQL sampling plans
• Ability to perform mathematical calculations.
• Legible Handwriting
• Any Lean Six Sigma or process improvement training is a plus.

LANGUAGE SKILLS :

Highly developed oral and written interpersonal communication skills to effectively communicate with company management.

COMPUTER SKILLS :

The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g.).

LI-SW1

Join us and be part of building the bridge between life changing therapies and patients.