QA Associate, IPQA

Prostaffworkforce; New Brunswick (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A prominent pharmaceutical company in New Brunswick is seeking a QA Associate, IPQA, to join their team. This role focuses on ensuring compliance with cGMP while identifying and managing deviations in manufacturing processes. Successful candidates will have a Bachelor's degree, a minimum of two years of experience in quality roles, and strong interpersonal and communication skills. The company offers a competitive compensation package with excellent benefits.

Benefits

Competitive compensation package

Excellent benefits for eligible candidates

Qualifications

• Two years of experience in a quality function in the pharmaceutical industry.
• Experience in an international multicultural matrix organization.
• Knowledge of project management principles.

Responsibilities

• Identify deviations and ensure compliance with cGMP.
• Perform area assessments and manage deviations/investigations.
• Collaborate with Quality Engineers for thorough investigations.

Skills

Communication

Time Management

Project Management

Interpersonal Skills

Education

Bachelor’s degree

Tools

TrackWise

MS Office

Job description

Are you looking to be a part of a growing pharmaceutical company? One of our largest clients is currently seeking a QA Associate, IPQA (In-Process Quality Assurance) to join their New Brunswick, New Jersey 08901 team. Our client is one of the leading pharmaceutical companies specializing in developing and manufacturing solid dosage products. If you believe you are qualified, we would be excited to connect and discuss this opportunity in more detail.

Direct Hire

Job Summary:
The IPQA Associate I is responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.

Job Description:
•Focuses on initial deviation investigative phases related to manufacturing process deviation
•Responds to customer calls for assistance, documentation and immediate corrective action associated with deviations
•Facilitates the use of existing management processes regarding deviations, investigations, and preventive actions
•Performs area assessments and ensures compliance with SOPs, Policies and Procedures
•Leverage on-the-floor presence to proactively identify opportunities and provide coaching
•Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place
•Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities
•Administration and management of deviations/investigation/PAC systems in Trackwise
•Control materials for compliance purposes in SAP
•Execute the final release inspection of packaging lines
•Perform acceptance sample analysis for validation and investigation support
•Responsible for the review and approval of controlled documents including manufacturing and packaging batch records
•Actively communicate with customers to facilitate continuous process improvement
•May complete specific project work such as process improvement/remediation, maintain ownership and responsibility for specific QA processes
•While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear
•The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend


Qualifications:
•Minimum of Bachelor’s degree
•Minimum two (2) years of experience within the pharmaceutical industry in quality function role
•Experience working in an international multicultural matrix organization
•Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc
•Knowledge of project management principles, practices, techniques and tools
•Strong interpersonal and communication, both written and verbal, skills
•Strong organizational and time management skills; must be able to prioritize and manage multiple assignments simultaneously
•A self-starter with a hands-on approach and a can-do attitude
•The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR)

Our client offers a competitive compensation package as well as an excellent benefits package for eligible candidates.

Please visit us at https://www.prostaffworkforce.com/ to explore all opportunities.

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