Randstad Quality Assurance Inspector in Cambridge, Massachusetts
Quality Assurance Inspector
salary:$35 - $38.95 per hour
date posted:Thursday, March 7, 2019
industry:Professional, Scientific, and Technical Services
Quality Assurance Inspector
This individual will be responsible for supporting the Commercial Quality Assurance team with day to day operations, including lot review activities for commercial drug substance, drug product and finished goods manufactured by CMOs.
This individual will support project activities, change controls, investigations, product complaints, and other quality systems as they relate to commercial manufacturing.
This person will be critical in providing quality oversight and coordination of QA activities with CMOs.
This person will be responsible for managing own workload from multiple project managers to meet deadlines.
location: Cambridge, Massachusetts
job type: Contract
salary: $35.00 - 38.95 per hour
work hours: 9 to 5
Performs documentation review, including but not limited to investigations, deviations, and executed batch records, thoroughly, with a high attention to detail, using working knowledge of cGMPs and internal procedures and controls.
Communicates with manager and other stakeholders (internal and external) to ensure communication of outcomes.
Able to identify and escalate basic technical issues using problem-solving skills, in consultation with management and other cross functional departments.
Maintain Master Batch Records and provide support for regulatory filings and change controls.
Provide support for regulatory inspections and GMP audits
Responsible for engaging with internal and external organizations to ensure batch release timelines are met and issues are resolved.
Actively participates in the planning and prioritization of multiple projects and/or the resolution of quality and compliance issues.
Supports CAPA investigations including proposing corrective and preventative actions and effectiveness checks.
Performs all required trainings on time. Actively participates in group trainings and coaching efforts.
Evaluates supplier quality performance and conducts periodic supplier certification assessments as required.
Compiles quality metrics demonstrating CMO site performance when requested.
Actively integrates big picture understanding into all interactions. Drives team cooperation and credibility focusing on positive results. Encourages communication, cooperation and win/win solutions.
Performs additional duties, as assigned.
BS and 3+ years experience in QA or related compliance experience or MS and 1+ years QA experience. Experience may be substituted for degree.
Solid understanding of cGMPs as well as applicable regulations and guidances. Demonstrates expertise of department processes, tools and methods.
Ability to handle multiple tasks concurrently and in a timely fashion.
Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
Must be able to read, write and converse in English.
Must display eagerness to learn and continuously improve.
Positive work attitude that supports teamwork and continuous improvement.
Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.