Description
ProStaff Solutions is looking for In-Process Quality Assurance (IPQA) Associate to work with a pharmaceutical company in New Brunswick, NJ.
Pay Rate - $30/hr
Contract
Job Description:
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
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 Bachelors 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)
Must be capable of bending and lifting, moving and/or carrying up to approximately 20 pounds
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes