Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
true
Auditor
RE, MA 00000 US
Posted: 03/17/2025
2025-03-17
2025-04-24
Employment Type:
Contract
Job Category: Quality and Compliance
Job Number: 617716
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 80-90/hr
*Depending on experience
 Duties:
MUST BE ABLE TO SPEAK FLUENT SPANISHÂ
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Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques. Analyzes regulatory requirements and overall program compliance to determine enterprise risk. Proposes and/or implements audit program enhancements. Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation. Communicates best practices observed to other business units. Prepares for audits by researching materials, standards, policies and procedures to formulate a plan of action. Coordinates and supervises the daily activities of operations, or business support staff Administers and executes policies and procedures Ensures employees operate within guidelines Decisions have a direct impact on work unit operations and customers Frequently interacts with subordinates, customers and peer groups at various management levels Interactions normally involve information exchange and basic problem resolution Accountabilities Responsible for Quality Systems and various initiatives within the organization's facility Manage the organization's CAPA system to ensure compliance with regulations and corporate guidelines Serve as a Subject Matter Expert of the CAPA system, assisting the plant on all aspects of CAPA Provide metric updates pertaining to CAPA Training to the CAPA Process / System
Skills:
What is expected of you and others at this level Manage the Quality System training development, ComplianceWire system, deployment and effectiveness Maximize the use of cross-functional training and the assignment of roles and responsibilities to ensure compliance while optimizing productivity, workflow and teamwork to meet business needs Manage the organization's Internal Audit system to ensure compliance with regulations and corporate guidelines Serve as a Subject Matter Expert of the Internal Audit system, assisting the plant on all aspects of IA Provide metric updates pertaining to IA Perform supplier audits both in an assistant audit and lead auditor role, write audit reports and finalize audit closure activities Training to the IA Process / System Perform organization's internal as a lead auditor, write audit reports and finalize audit closure activities Development of IA Schedule as well as auditors and ensure compliance to schedule Maintain organization's’s Controlled Documentation System by updating current or new documents in the approved format. Notify necessary personnel of changes and new documents. Manage the Change Control Process for approved artwork and other required documents for distribution in-house. Revise or create new documents per the approved change. Control the management of the distribution of all controlled documents (General Specifications, Lab Specifications, RMPS, and Drawings, etc. ) that are distributed in-house. Establish accounts for new CAP users. Facilitate the training. Provide training records to training Coordinator Serve as primary resource for creating new labels, proofing artwork for printed materials and maintaining labeling software Coordinate training curriculum integration into all organization's DEPTs and facilitate integration of the systems to maintain compliance to regulations In working collaboratively with the Document Control system develop a closed loop system by which new revisions of documents automatically trigger training requirements in Compliance Wire Develop reports to escalate pending and overdue training, manage the reports and escalate to leadership Ensure compliance with Division and Corporate policies (i.e. ISO 13485, 21 CFR Part 20) Serve as a backup for activities regarding Certificates of Analysis/Certificates of Manufacture/Certificates of Conformance to ensure compliance to approved Finished Goods Develop monthly metric reporting and manage monthly metric meetings, including CAB meetings, Management Reviews, and NCR meetings Work with Leadership Team to assemble Management Review presentation, document minutes and assure the closed loop of actions Work with leadership team to assemble Correct Action Board (CAB) presentation, document minutes and assure the closed loop of action items. Compile facility monthly quality metrics and assist with other metric inputs and reporting on an as needed basis
Education:
Bachelors in related field, or equivalent work experience, preferred 3-5 years experience in related field, preferred
Languages: English  Read  Write  Speak Spanish  Read  Write  Speak Certifications & Licenses: CAPA
Serve as a backup for activities regarding Certificates of Analysis
Â
*Depending on experience
 Duties:
MUST BE ABLE TO SPEAK FLUENT SPANISHÂ
Â
Demonstrates comprehensive knowledge of regulatory requirements in their respective areas, as well as auditing techniques. Analyzes regulatory requirements and overall program compliance to determine enterprise risk. Proposes and/or implements audit program enhancements. Ensures compliance with regulations and controls by examining and analyzing records, reports, operating practices, and documentation. Communicates best practices observed to other business units. Prepares for audits by researching materials, standards, policies and procedures to formulate a plan of action. Coordinates and supervises the daily activities of operations, or business support staff Administers and executes policies and procedures Ensures employees operate within guidelines Decisions have a direct impact on work unit operations and customers Frequently interacts with subordinates, customers and peer groups at various management levels Interactions normally involve information exchange and basic problem resolution Accountabilities Responsible for Quality Systems and various initiatives within the organization's facility Manage the organization's CAPA system to ensure compliance with regulations and corporate guidelines Serve as a Subject Matter Expert of the CAPA system, assisting the plant on all aspects of CAPA Provide metric updates pertaining to CAPA Training to the CAPA Process / System
Skills:
What is expected of you and others at this level Manage the Quality System training development, ComplianceWire system, deployment and effectiveness Maximize the use of cross-functional training and the assignment of roles and responsibilities to ensure compliance while optimizing productivity, workflow and teamwork to meet business needs Manage the organization's Internal Audit system to ensure compliance with regulations and corporate guidelines Serve as a Subject Matter Expert of the Internal Audit system, assisting the plant on all aspects of IA Provide metric updates pertaining to IA Perform supplier audits both in an assistant audit and lead auditor role, write audit reports and finalize audit closure activities Training to the IA Process / System Perform organization's internal as a lead auditor, write audit reports and finalize audit closure activities Development of IA Schedule as well as auditors and ensure compliance to schedule Maintain organization's’s Controlled Documentation System by updating current or new documents in the approved format. Notify necessary personnel of changes and new documents. Manage the Change Control Process for approved artwork and other required documents for distribution in-house. Revise or create new documents per the approved change. Control the management of the distribution of all controlled documents (General Specifications, Lab Specifications, RMPS, and Drawings, etc. ) that are distributed in-house. Establish accounts for new CAP users. Facilitate the training. Provide training records to training Coordinator Serve as primary resource for creating new labels, proofing artwork for printed materials and maintaining labeling software Coordinate training curriculum integration into all organization's DEPTs and facilitate integration of the systems to maintain compliance to regulations In working collaboratively with the Document Control system develop a closed loop system by which new revisions of documents automatically trigger training requirements in Compliance Wire Develop reports to escalate pending and overdue training, manage the reports and escalate to leadership Ensure compliance with Division and Corporate policies (i.e. ISO 13485, 21 CFR Part 20) Serve as a backup for activities regarding Certificates of Analysis/Certificates of Manufacture/Certificates of Conformance to ensure compliance to approved Finished Goods Develop monthly metric reporting and manage monthly metric meetings, including CAB meetings, Management Reviews, and NCR meetings Work with Leadership Team to assemble Management Review presentation, document minutes and assure the closed loop of actions Work with leadership team to assemble Correct Action Board (CAB) presentation, document minutes and assure the closed loop of action items. Compile facility monthly quality metrics and assist with other metric inputs and reporting on an as needed basis
Education:
Bachelors in related field, or equivalent work experience, preferred 3-5 years experience in related field, preferred
Languages: English  Read  Write  Speak Spanish  Read  Write  Speak Certifications & Licenses: CAPA
Serve as a backup for activities regarding Certificates of Analysis
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