Job Title: QA Specialist
Job Function: Performs the audit and complete product disposition process
Job Type: Full Time 6 months Contract
Location: Barceloneta, PR (On-Site)
Shift:First shift. Normally 8 hours shift, but exceptions can occur based on workload

About RCM:RCM IT &amp;
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 JobRCM is looking for a QA Specialist to performs the audit and complete product disposition process for our pharmaceutical client in Barceloneta, Puerto Rico.
Responsibilities * Audit Bulk Drug Substance electronic and/or manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.


* Evaluate potential discrepancies detected in batch records and determine the need for a corrective action.
* Approve MES exceptions related to production support.
* Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.


 Qualifications * Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)
* Audit experience
* Excellent oral and written communication skills in English and Spanish
* Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is preferable.


 Education &amp;
Certifications * Bachelor's Degree in Science (preferably in Biology, Chemistry, Biotechnology or Engineering) with minimum of2 years of experience.
 Equal Opportunity StatementRCM 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.


DisclaimerThis 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.

#Monster

<strong>Job Title:</strong> QA Specialist<br /><strong>Job Function:</strong> Performs the audit and complete product disposition process<br /><strong>Job Type: </strong> Full Time 6 months Contract<br /><strong>Location:</strong> Barceloneta, PR (On-Site)<br /><strong>Shift</strong>:First shift. Normally 8 hours shift, but exceptions can occur based on workload<br /><br /><strong>About RCM:</strong><div>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.</div><br /><strong>Scope of Job</strong><div>RCM is looking for a QA Specialist to performs the audit and complete product disposition process for our pharmaceutical client in Barceloneta, Puerto Rico.</div><div><br /><strong>Responsibilities</strong></div><ul><li>Audit Bulk Drug Substance electronic and/or manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.</li><li>Evaluate potential discrepancies detected in batch records and determine the need for a corrective action.</li><li>Approve MES exceptions related to production support.</li><li>Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements. </li></ul> <strong> Qualifications</strong><ul><li>Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)</li><li>Audit experience</li><li>Excellent oral and written communication skills in English and Spanish</li><li>Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is preferable.</li></ul> <strong> Education & Certifications</strong><ul><li>Bachelor's Degree in Science (preferably in Biology, Chemistry, Biotechnology or Engineering) with minimum of2 years of experience.</li></ul> <strong> Equal Opportunity Statement</strong><div>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.</div><br /><strong>Disclaimer</strong><div>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.<br /><br />#Monster</div><div></div>

Job Title: QA Specialist
Job Function: Performs the audit and complete product disposition process
Job Type: Full Time 6 months Contract
Location: Barceloneta, PR (On-Site)
Shift:First shift. Normally 8 hours shift, but exceptions can occur based on workload

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 JobRCM is looking for a QA Specialist to performs the audit and complete product disposition process for our pharmaceutical client in Barceloneta, Puerto Rico.
Responsibilities * Audit Bulk Drug Substance electronic and/or manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.


* Evaluate potential discrepancies detected in batch records and determine the need for a corrective action.
* Approve MES exceptions related to production support.
* Give timely disposition to manufactured products in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.


 Qualifications * Knowledge of Quality regulations and standards affecting chemical, biological or medical devices (i.e. Quality Systems, FDA regulations, etc.)
* Audit experience
* Excellent oral and written communication skills in English and Spanish
* Knowledge and experience in SAP, LIMS, MES and biotechnology manufacturing process is preferable.


 Education &
Certifications * Bachelor's Degree in Science (preferably in Biology, Chemistry, Biotechnology or Engineering) with minimum of2 years of experience.
 Equal Opportunity StatementRCM 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.


DisclaimerThis 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.

#Monster

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