Quality Assurance Technical Specialist - RCM Technologies (USA), Inc.
Barceloneta, PR 00617
About the Job
Job Title: Quality Assurance Technical Specialist
Job Function: Support the approval of all laboratory documents.
Job Type: This is approximately a One (1) year full time contract services.
Location: Barceloneta, PR (On-Site)
About RCM:
RCM 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 Puerto Rico and USA.
Scope of Job
RCM Technologies is looking for a Quality Assurance Technical Specialist in Barceloneta, PR.
Primary Responsibilities
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.
Job Function: Support the approval of all laboratory documents.
Job Type: This is approximately a One (1) year full time contract services.
Location: Barceloneta, PR (On-Site)
About RCM:
RCM 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 Puerto Rico and USA.
Scope of Job
RCM Technologies is looking for a Quality Assurance Technical Specialist in Barceloneta, PR.
Primary Responsibilities
- Experience related to change management, validations, generation and approval of SOP, with some experience in the laboratory as it will support the approval of all laboratory documents.
- Give support for periodic review of the laboratory.
- Responsible for assigned equipment calibrations including verification and preventive maintenance.
- Responsible for reviewing instrument calibration packages and subsequent equipment release-for-use.
- Equipment periodic reviews.
- Verify, review, and approve equipment unscheduled maintenances (UMs), out-of-tolerance (OOT) notifications and reports, documentation reconciliation and archive, among others.
- Manage change requests (CRs) activities associated to laboratory activities including equipment qualification, external testing, modification of testing methods, substitution of raw materials, among others.
- Collaborate with Regulatory personnel and participate in strategy design and Quality Agreements with laboratory personnel and suppliers for laboratory equipment (including closely working with vendors to execute internal equipment risk assessments and subsequent equipment acquisition, VWR service agreements, and so on).
- Provide of technical laboratory support on new systems, processes, and techniques from a Quality Operations (QO) perspective.
- Responsible for approval of validation activities for new, modified or changed laboratory equipment/instrumentation (all phases of equipment qualification including but not limited to user requirements, vendor specifications, design qualification, ALCOA assessments, installation/operational/performance qualifications, final qualifications reports, among others).
- Approval of Trending Reports for Empower, Environmental Monitoring, Purified, Potable, Soft Water, etc.
- Good skills revising documentation in English and using MS Office applications.
- Fully bilingual (Spanish/English) communication skills, both written and verbal.
- Self-motivated, creative and teamwork oriented
- Technical and scientific capability to make firm decisions and recommendations
- Excellent interpersonal skills and the ability to interact with people at all levels
- Bachelor's degree in Science or Engineering or related area
- Minimum of 5-7 years in QA of directly related experience in the Pharmaceutical Industry.
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.
Source : RCM Technologies (USA), Inc.