Incoming QA Inspector

PCI Pharma Services•Philadelphia, PA

About The Position

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. Incoming Quality Assurance (IQA) Inspector Summary of Objective: The Incoming Quality Control Inspector is responsible for verifying incoming materials received from suppliers is following company drawings, specifications, and requirements. The verification process includes, but is not limited to current revision, total quantity, material type, physical dimensions, aesthetic appearance, etc. and will involve the use of inspection equipment such as calipers, micrometers, scales, balances, go/no-go gauges, etc. The position will also be responsible for interacting with the purchasing, engineering, and production personnel to determine the cause and disposition of non-conforming material. 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 Incoming Quality Assurance (IQA) related to the inspection, control, disposition, and release of incoming material. · Maintaining inspection 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 inspection process. · Create detailed documentation (pictures, PowerPoint presentations, etc.) of non-conforming material to effectively communicate the issue to the appropriate supplier. · 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 and with customers to secure missing documentation (i.e. Certificate of conformance, Certificate of Analysis, etc.) in order to ensure that all Quality expectations and parameters have been met and to expedite release of the material. · Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives. Responsible for acting as the quality representative on capital projects. · Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information, and presenting to inspectors on required topics. · Provides training to new incoming personnel and ensures compliance with departmental procedures. · Interacting with customers in order to answer Quality related questions in a professional and courteous manner.

Requirements

High school education or at least (2) years of pharmaceutical, scientific, or pharmaceutical packaging experience.
Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
Knowledge of basic test instrumentation such as scales, balances, micrometers, calipers, rulers, etc.
Strong problem-solving skills and detailed oriented.
Basic understanding of cGMP requirements and AQL sampling plans
Legible Handwriting
Highly developed oral and written interpersonal communication skills to effectively communicate with company management, customers, suppliers, and agencies at all levels.
The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g.).
Ability to create, use and interpret scientific tables, charts, and graphs.

Nice To Haves

Any Lean Six Sigma or process improvement training is a plus

Responsibilities

Ability to understand and execute all aspects of the activities performed in Incoming Quality Assurance (IQA) related to the inspection, control, disposition, and release of incoming material.
Maintaining inspection 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 inspection process.
Create detailed documentation (pictures, PowerPoint presentations, etc.) of non-conforming material to effectively communicate the issue to the appropriate supplier.
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 and with customers to secure missing documentation (i.e. Certificate of conformance, Certificate of Analysis, etc.) in order to ensure that all Quality expectations and parameters have been met and to expedite release of the material.
Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives. Responsible for acting as the quality representative on capital projects.
Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information, and presenting to inspectors on required topics.
Provides training to new incoming personnel and ensures compliance with departmental procedures.
Interacting with customers in order to answer Quality related questions in a professional and courteous manner.