Incoming QA Inspector

PCI Pharma Services; Philadelphia (Philadelphia County); On-site; USD 45,000 - 65,000; Full time

Job summary

PCI Pharma Services in the United States is seeking an Incoming Quality Control Inspector to verify incoming materials against drawings and specifications, using calipers, micrometers, scales, and other inspection tools. You will interact with purchasing, engineering, and production to determine disposition of non-conforming material.

The role requires strong organizational skills, knowledge of CQ management systems, and experience with basic inspection instrumentation.

Qualifications

• Excellent organizational, time management and multitasking to meet deadlines.
• Knowledge of basic test instrumentation (scales, balances, micrometers, calipers).
• Strong problem-solving and detail-oriented.
• Basic understanding of cGMP requirements and AQL sampling plans.
• Legible handwriting.
• Lean Six Sigma or process improvement training is a plus.

Responsibilities

• Understand and execute IQA activities related to inspection, control, disposition, and release of incoming material.
• Maintain inspection records and procedures compliant with Quality Management System and regulations.
• Record inspection results and disposition material per approved processes.
• Process material transactions accurately throughout inspection.
• Document non-conforming material with photos and reports to communicate issues to suppliers.
• Collaborate effectively with team members to improve quality.
• Represent Quality on project teams and lead quality-related initiatives.
• Follow up with internal teams and customers to secure missing documentation (COC, COA).
• Support strategic quality initiatives and act as quality representative on capital projects.
• Participate in site inspections/audits and present topics to inspectors.
• Provide training to new incoming personnel and ensure compliance.
• Interact with customers to answer quality-related questions professionally.

Skills

Quality inspection

Dimensional inspection

Documentation

Problem solving

Attention to detail

Tools

Calipers

Micrometers

Scales

Balances

Go/no-go gauges

Rulers

Job description

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 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.
• Maintain 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.

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.

#LI-DT1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.