Quality Assurance Specialist

United Pharma Technologies Inc; Ohio; On-site; USD 51,000 - 73,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement benefits

Job summary

United Pharma Technologies Inc. is seeking a Quality Assurance (QA) Specialist with pharmaceutical industry experience to support quality operations, commissioning and qualification activities, CAPA management, and batch disposition.

The role requires strong knowledge of cGMP and ensuring quality compliance in a pharmaceutical manufacturing environment. Responsibilities include supporting QA activities, reviewing CQ documentation, participating in CAPA investigations, and ensuring batch records

Qualifications

• Pharmaceutical QA experience in a manufacturing environment.
• Hands-on commissioning and qualification (C&Q) activities.
• Strong CAPA, deviation management, and root cause analysis knowledge.
• Experience with batch records review and batch disposition.
• Understanding of cGMP regulations and pharmaceutical quality systems.
• Strong documentation, investigation, and communication skills.

Responsibilities

• Support QA activities in a pharmaceutical manufacturing environment in accordance with cGMP requirements.
• Review and support commissioning and qualification documentation for equipment, utilities, and manufacturing systems.
• Participate in CAPA investigations, root cause analysis, and corrective and preventive actions.
• Review batch manufacturing records and documentation for completeness, accuracy, and compliance.
• Support batch disposition activities by evaluating documentation and ensuring quality requirements are met before batch release.
• Investigate deviations, discrepancies, and nonconformances and assist with timely resolution.
• Collaborate with Manufacturing, Engineering, Validation, and Quality Control teams to maintain inspection readiness.
• Ensure quality documentation complies with procedures, regulatory requirements, and internal standards.

Skills

QA experience

CQ activities

CAPA investigations

Root cause analysis

Documentation

Communication

Batch record review

Batch disposition

Investigations

Job description

Company: United Pharma Technologies Inc.

Employment Type: Contract

Duration: 6+ Months

Project:

We are seeking a Quality Assurance (QA) Specialist with pharmaceutical industry experience to support quality operations, commissioning and qualification activities, CAPA management, and batch disposition. The ideal candidate will have a strong understanding of cGMP requirements and experience maintaining quality compliance in a pharmaceutical manufacturing environment.

Responsibilities:

• Support Quality Assurance activities in a pharmaceutical manufacturing environment in accordance with cGMP requirements.
• Review and support commissioning and qualification documentation for equipment, utilities, and manufacturing systems.
• Participate in CAPA investigations, root cause analysis, and the implementation of corrective and preventive actions.
• Review batch manufacturing records and associated documentation for completeness, accuracy, and compliance.
• Support batch disposition activities by evaluating documentation and ensuring quality requirements are met before batch release.
• Investigate deviations, discrepancies, and nonconformances and assist with timely resolution.
• Collaborate with Manufacturing, Engineering, Validation, and Quality Control teams to maintain inspection readiness.
• Ensure quality documentation complies with applicable procedures, regulatory requirements, and internal standards.

Required Qualifications:

• Pharmaceutical industry experience in Quality Assurance.
• Hands-on experience with commissioning and qualification (C&Q) activities.
• Strong knowledge of CAPA, deviation management, and root cause analysis.
• Experience with batch record review and batch disposition.
• Understanding of cGMP regulations and pharmaceutical quality systems.
• Strong documentation, investigation, and communication skills.

Pay Scale: $45/hr on W2

Benefits: Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements.

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.