PHL_Quality Analyst

at  PCI Pharma Services

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 Quality Analyst has the primary function of conducting customer complaint investigations. The individual also performs support functions related to maintaining the overall Quality Management System.
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.
 Receive communications from customers related to complaints
 Log complaints into the QMS system
 Conduct investigations utilizing root cause analysis tools and work with other functional areas to identify
the cause and appropriate corrective and preventive actions
 Draft and peer review customer complaint investigations
 Communicate directly with clients in resolution of customer complaints
 Compile metrics for the functional area
 Assist with compiling information for regulatory filings
 Responsibility will include some facets of maintaining and improving the overall Quality Management Systems (i.e. internal audits, CAPA effectiveness, change control)

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE:

High school education or at least five (5) years of pharmaceutical or pharmaceutical packaging experience. A college degree with a concentration in a scientific discipline is preferred.
Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines. The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., TrackWise). Ability to create, use and interpret scientific tables, charts, and graphs.
Prior experience in technical writing and utilizing root cause analysis tools is preferred.
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, customers, suppliers, and agencies at all levels.

No supervisory responsibilities.
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
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.
The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
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 the essential functions.
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 the 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 the essential functions.