Incoming QA Inspector

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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.

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 move safely in a shipping/receiving environment.

• 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.

• 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.

  • 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 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

  • 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.

  • 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.).

  • Ability to create, use and interpret scientific tables, charts, and graphs.

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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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.