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Job Posting: Project Management (PM)

Job Posting: Project Management (PM) Duration: 3 to 6 months, Initial Term Positions: 1 Employment Type: ICQ W2 Location: Greater Baltimore Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting […]

Job Posting: Project Management (PM)

Job Posting: Project Management (PM) Duration: 3 to 6 months, Initial Term Employment Type: ICQ W2 Positions: 1 Location: Greater San Francisco Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities […]

Job Posting: Project Management (PM)

Job Posting: Project Management (PM) Duration: 3 to 6 months, Initial Term Positions: 1 Employment Type: ICQ W2 Location: Greater Boston Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting […]

Job Posting: Quality Assurance (QA)

Job Posting: Quality Assurance (QA) Duration: 6 Months to a year, Initial Term Positions: 1 Employment Type: ICQ W2 Location: Greater Boston Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting […]

Job Posting: Process Validation (PV)

Job Posting: Process Validation (PV) Duration: 3 to 6 Months, Initial Term Positions: 1 Employment Type: ICQ W2 Location: Greater San Francisco Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting […]

Job Posting: Computer System Validation (CSV)

Job Posting: Computer System Validation (CSV) Duration: 3 to 6 months, Initial Term Positions: 4 Employment Type: ICQ W2 Location: Greater Boston Area EDUCATION & EXPERIENCE REQUIREMENTS B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. RESPONSIBILITIES Successfully working within a multi-disciplinary team coordinating and delivering project activities meeting schedule, […]

Job Posting: Computer System Validation (CSV)

Job Posting: Computer System Validation (CSV) Duration: 6 months to 1 year Location: Greater Baltimore Area Education Requirements B.S. degree in Biology, Biochemistry, Chemistry, Engineering or equivalent years’ experience working in FDA-regulated industries. Responsibilities Assist in authoring and revising procedural controls, assessment forms or checklists, associated process work instructions, and potential ERES training materials. […]

By |August 26th, 2018|Categories: Job Postings|Tags: |0 Comments

Identifying System Boundaries in a few easy steps: so easy a cave man can do it!

Identifying System Boundaries in a few easy steps: so easy a cave man can do it! System boundaries are the foundation of the Engineering lifecycle.  These boundaries identify where one system ends and another begins.  System boundaries define the scope of a system and assist in the management of Validation, Maintenance and Change Management […]

By |August 25th, 2018|Categories: Uncategorized|Tags: |0 Comments

Resin Life Cycle Validation – An Important Factor in Any Validation Program

The purpose of performing resin life cycle validation is to demonstrate that the column resins for the process are capable of maintaining acceptable performance throughout the lifetime of the resin. It is also to demonstrate that the resin can be successfully cleaned and reused. The target number of resin cycles should be established through […]

12 Questions to Assess Your Data Integrity Compliance

How would your company do in the next regulatory audit on the hot topic of data integrity? I’ve had the opportunity, to interview and discuss recent FDA inspections with staff at multiple firms who primarily have a paper based data and documentation system. As one might think, a paper based organization shouldn’t have much […]