This range is provided by ECLARO. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$68.00/hr - $70.00/hr
Primary Recruiter : Froilyn Jane Bautista
Pay Rate : $68-70/Hour
Position Type : 1 Year Contract
Location : Summit, NJ, United States - 50% onsite required
Work Schedule: Mon-Fri (normal business hours)
Position Summary:
Responsible for the creation and execution of computer system validation documents as well as providing operational support and guidance related to system use and improvement.
Duties/Responsibilities:
- Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
- Provide electronic systems operational support and troubleshooting to end users.
- Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
- Own project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- Propose and implement improvements to electronic systems to optimize business processes and improve efficiency. Collaborate with end users to develop business cases.
- Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives.
- Anticipate and perform troubleshooting and problem-solving independently.
- Train and mentor others on electronic systems use and operation.
- Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution.
- Facilitate design, testing, and subsequent deployment of solutions.
- Support health agency inspection as equipment area subject matter expert.
- Perform other tasks as required to support the electronic systems.
Reporting Relationship
- This position will report to QC management.
Qualifications:
Specific Knowledge, Skills, Abilities:
- Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Ability to work in a fast-paced team environment, meet deadlines and prioritize work.
- Advanced technical, problem-solving skills and logical thinking.
- Ability to communicate effectively with peers, department management, and cross-functional peers.
- Mentoring, coaching, influencing, negotiating and personnel interaction skills.
Education/Experience/Licenses/Certifications:
- Bachelor’s degree required, preferably in science or related engineering field.
- 6+ years of relevant work experience in LIMS, ELN, and laboratory data analysis systems preferably in a regulated environment.
- Knowledge of analytical and microbiological test methods and environmental monitoring programs preferred.
- Demonstrated technical writing skills.
- Demonstrated experience with validation and/or maintenance of laboratory information systems.
Remarks:
- 50% onsite
- Bachelor's degree required
- Work Schedule: Mon-Fri (normal business hours)
Must Haves:
- Create, deploy, review, and sustain electronic systems Master Data.
- Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
Seniority level
Employment type
Job function
- Information Technology and Quality Assurance
- Pharmaceutical Manufacturing and Biotechnology Research
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