Über
Manage the operations of systems in a validated environment and develop policies and procedures related to compliance requirements; Work with end users to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.
Develop, revise, and review SOPs, protocols and reports and other documents to support equipment, platforms, and other computerized systems.
Develop and provide computerized system training to new users and grant system access and ensure lab compliance with applicable cGMP regulations and SOPs, and support both internal and external audits; Collect and report metrics.
Manage system updates, change controls and maintenance activities as relating to systems.
Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.
Create/manage master data to support existing/new system functionalities.
Ensures that the integrity and accuracy of all documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
Qualifications: Required: B.S. degree in biological sciences, cell biology, chemistry, or related field with 7+ years or M.S. degree with 5+ years of relevant experience in working with analytical computerized systems
Prior laboratory hands-on experience with a variety of analytical computerized systems
Expertise in regulations governing data integrity and computerized systems
Experience in qualification of analytical equipment, including those with computerized systems
Experience with electronic document management systems
Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
Strong knowledge of GMP, SOPs and quality control processes
Strong knowledge of quality systems and regulatory requirements
Experience and knowledge in implementation and management of LIMS
Experience in translating laboratory user requirements to IT implementations
Experience with Windows OS, domains, networks and basic computing infrastructure in lab/production environment
Good to excellent technical writing skills and verbal communication skills
Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
Highly self-motivated and goal oriented
Will support and demonstrate quality standards to ensure data of highest quality
Preferred Experience in a small company and high growth, fast-paced environment
Experience working with additional electronic laboratory systems such as ERP, BMRAM, Empower, LabX.
Experience with instrument integration/direct data capture from stand-alone COTS systems to LIMS application
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws. Location: Westborough , MA Minimum Experience (yrs): Required Education: Bachelor (BA, BS...) Benefits: Return to search results Email this job to a friend (emailjobs.asp?jo_num=362922) If you have previously registered with us, pleaseLog in (memberlogin.asp) to apply for this position. *Logged in members may also add jobs to their job cart
Sprachkenntnisse
- English
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