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Devens, MA Date Posted: 07-27-2020
Job Summary: Seeking a QA Specialist to provide oversight and guidance for deviation assessment, impact assessment, root cause analysis, and CAPA planning activities.
Qualifications: B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required. A minimum of 4 years relevant experience with a minimum of 2 years in a regulated envi
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Compliance Specialist
New Brunswick, NJ Date Posted: 07-27-2020
Job Summary: Seeking a Compliance Specialist to provide quality/compliance oversight to all computer system validation related activities across the GPS enterprise.
Qualifications: Bachelor’s Degree in a related field from an accredited college or university, with a minimum of 5 years of related experience
Has knowledge of: 21CFR11/ EU GMP Annex 11 and GAMP 5 s
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AQ&C Specialist
Devens, MA Date Posted: 07-27-2020
Job Summary: Seeking an AQ&C Specialist to focus on QA review and approval of technical documents pertaining to GMP analytical methods for biologics (large molecules) drug substances and drug products.
Qualifications: Working knowledge of QC, QA, analytical method development or method validation functions
Understanding and knowledge of FDA guidelines and GxP regulations. Excellent communication sk
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PMC Technician
Sunnyvale, CA Date Posted: 07-27-2020
Job Summary: Seeking a PMC Technician to assess failure modes of semi-automated and automated test equipment, complete on-site preventive maintenance of equipment throughout facilities.
Qualifications: High school diploma or equivalent
Minimum of 2 years related experience or training. Proficient in SAP PMC Module (establishment of Work Orders, notification, Activation and Inactivat
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TMF Study Lead
Lawrenceville, NJ Date Posted: 07-27-2020
Job Summary: Seeking a TMF Study Lead to monitor and identify TMF trends and escalate concerns to management.
Qualifications: Minimum of Bachelor’s degree in a scientific or related discipline
At least 5 years of TMF experience required, including experience in study start-up, maintenance and closeout, and
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Clinical Trial Payments Coordinator
Lawrenceville, NJ Date Posted: 07-27-2020
Job Summary: Seeking a Clinical Trial Payments Coordinator to manage document retrieval, review and data entry for global clinical trial site payment configuration.
Qualifications: Bachelor’s Degree
Minimum of 3 years related work experience
Experience in financial or health sciences or related industries (pharmaceutical, hospital-based, laboratory, CRO, etc.)
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Business Support Specialist
Newark, NJ Date Posted: 07-27-2020
Job Summary: Seeking a Business Support Specialist to evaluate data from multiple sources and do accurate data entry.
Qualifications: Knowledge of Excel, Microsoft Word, and Outlook
Able to work with different teams and independently
Self-starter
SAP is helpful
Detail oriented
Must meet regulatory requirements. Mu
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Regulatory Associate
Rockville, MD Date Posted: 07-27-2020
Job Summary: Seeking a Regulatory Associate to identify and escalate regulatory or programmatic issues while proposing mitigations strategies and solutions/problem solving.
Qualifications: Bachelor’s degree (Science) or advanced degree
6+ years significant experience in regulatory affairs or appropriate relevant experience in scientific function combined with at least
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Master Data Governance Lead
New Brunswick, NJ Date Posted: 07-27-2020
Job Summary: Seeking a Master Data Governance Lead to build data as an enterprise asset helping drive best in class data management activities, customer satisfaction, revenue growth and operational productivity.
Qualifications: Experience in the development of Enterprise AI and Machine Learning policies
Experience in establishing value from data frameworks
3 years experience with GDPR and other Global privac
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TMF Study Lead
Lawrenceville, NJ Date Posted: 07-27-2020
Job Summary: Seeking a TMF Study Lead to manage complex export requests for Health Authorities and divestitures and independently solve technical issues.
Qualifications: Minimum of Bachelor’s degree in a scientific or related discipline
At least 5 years of TMF experience required, including experience in study start-up, maintenance and closeout, and
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Lab System Specialist
Devens, MA Date Posted: 07-27-2020
Job Summary: Seeking a Lab System Specialist to support Quality Control data management systems primarily through use of Laboratory Information Management Systems (LIMS).
Qualifications: B.S. in science, computer science, engineering, biochemistry, a related discipline, or its equivalent is preferred. Working knowledge of databases and laboratory applications includin
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Repair Services Associate
Bentonville, AR Date Posted: 07-27-2020
Job Summary: Seeking a Repair Services Associate to create work instructions, check sheets, or other process documentation.
Qualifications: High school education. 1-3 years of related experience. Basic computer skills
Prior use of hand tools
Repair experience a plus
Basic knowledge of Android a plus
General math skill
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