QA Specialist Job at RCM Technologies (USA), Inc.
Job Title:
QA Specialist
Job Function: Support Laboratory Projects
Job Type: Full Time One Year Contract
Location: Manati, PR (Hybrid)
About RCM:
RCM Life Sciences & IT 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 One (1) QA Specialist with experience with laboratory equipment for our pharmaceutical client in Manati, Puerto Rico.
Primary Responsibilities
Disclaimer
Job Function: Support Laboratory Projects
Job Type: Full Time One Year Contract
Location: Manati, PR (Hybrid)
About RCM:
RCM Life Sciences & IT 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 One (1) QA Specialist with experience with laboratory equipment for our pharmaceutical client in Manati, Puerto Rico.
Primary Responsibilities
- Act as a regulatory guide
- Help define validation strategies
- Review and approve GMP documents, as well as deviations.
- Support of Client Quality Assurance program under minimal supervision.
- Review and approve laboratory equipment protocols and reports.
- Request Quality on incident triage team.
- Approve planned incidents.
- Represent QA on validation team.
- Own site quality program procedures.
- Review Risk Assessments.
- Approve NC investigations, change control and CAPA records.
- Approve change controls.
- Strong knowledge of and experience with laboratory equipment qualification.
- Strong organizational skills, including ability to follow assignments through to completion,
- Initiate and lead cross functional teams,
- Enhanced skills in leading, influencing and negotiating,
- Strong knowledge in area of expertise,
- Collaborate and coordinate with higher level outside resources,
- Demonstrate ability to interact with regulatory agencies,
- Strong communication (both written and oral), facilitation and presentation skills,
- Strong skill in working independently and to effectively interact with various levels,
- Good skills writing validation/commissioning, and technical documentation in English and using MS Office applications.
- BS or higher in Chemistry/Biology/Microbiology/Computer Science/Information Systems/Engineering or related discipline with 4+ years of experience on validation at the pharmaceutical specifically with laboratory equipment.
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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