Lab Investigations Specialist

Job Title: Lab Investigation Specialist
Job Function: Develop written reports using technical writing skills including but not limited to: summaries, investigation plans and investigation results in alignment with Non-conformance and CAPA process requirements.
Job Type: Full Time 6 months Contract with the option of extension
Location: Barceloneta, PR (On-Site)

About RCM:

RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. 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.

Scope of Job

RCM is looking for a Lab Investigation for our pharmaceutical client in Barceloneta, Puerto Rico.

Responsibilities

• Executes completion of CAPAs, Quality Events (QEs), memorandums, and deviations, as they pertain to the EM program.
• Ensures investigations are completed in a timely manner.
• Coordinates with EM, R&D, and other departments to ensure all training related to Microbiology investigations, excursions, and Quality Events are completed.
• Ensures all investigations and associated documentation pertaining to EM are completed in a thorough, expeditions manner.
• Understands Microbiology-related guidance, including, but not limited to USP, FDA, and compendial standards.
• Coordinates with impacted departments to ensure training related to investigations are completed.
• Prepares reports and data for EM tracking and trending, as well as tracking and reporting QEs, excursions, and CAPAs.
• Updates and maintains the EM Quality Event matrix electronic logs, including excursion and memorandum tracking.
• Communicates microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the Microbiology Investigations Manager, Assistant Director of Microbiology, Director of Microbiology, or designee.
• Assist in other activities, as needed.

Qualifications:

• Experience with Investigations tools (Root Cause Analysis, Fishbone, 5's Why's) in parenteral industries.
• Experience in Technical Writing.
• Experience in Laboratory Investigations.
• Experience with MS Word, Excel, and PowerPoint.
• Excellent written and oral communication skills.
• Team Player, must be able to interact with all departments within the company
• Experience and understanding of the 6M Methodology.
• Specific expertise, skills, and knowledge within Microbiology gained through education and experience.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, thinks globally, and leverages diversity.

Education & Certifications

• Bachelor's Degree in Science, preferably Microbiology, Biology, Chemistry or Biochemistry with 4 years of experience in a related field.

Equal Opportunity Statement

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. 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.

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