Laboratory Equipment Qualification Specialist

Job Title: Laboratory Equipment Qualification Specialist
Job Function: Equipment Qualification (HPLC, IV, GC)
Job Type: Full Time 6 months Contract with the possibility of extension
Location: Barceloneta, PR (On-Site)

Scope of Job
RCM is looking for resource to provide Laboratory Equipment Qualification services for our pharmaceutical client in Barceloneta, Puerto Rico.
Primary Responsibilities
Development and execution of Laboratory Equipment Validation (HPLC, UV, GC)
Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs.
Execution of related validation protocols.
Development of documentation packages for all activities, including Original format documents, approved document and applicable drawings.
Qualifications
2nd shift (2:00pm -10:00pm) Monday thru Friday
Must be fully bilingual (English / Spanish) with excellent oral and technical writing skills.
Must be proficient using MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
Strong knowledge in QC Laboratory Equipment.
Education & Certifications
Bachelor's Degree in Science or Engineering with minimum of 3+ years of experience in direct pharmaceutical, medical device or biotechnology industries.
Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.

Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

About RCM:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.