American Regent, Inc.
Inspection and Packaging Document Control Coordinator I
American Regent, Inc., New Albany, Ohio, United States, 43054
Inspection and Packaging Document Control Coordinator I page is loaded## Inspection and Packaging Document Control Coordinator Ilocations:
New Albany, OHtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-103022**Nature and Scope** The Inspection and Packaging Document Control Coordinator I works with the Inspection and Packaging department in the activities associated with the Inspection and Packaging GMP documentation (Manufacturing SOPs, Manufacturing Batch records, protocols, reports, specifications, etc.) in accordance with company procedures and cGMPs. The Inspection and Packaging Document Control Coordinator I ensures work is completed in a timely manner and in accordance with company standards. The role plays a critical role in assuring safe, effective and compliant activities are performed in the Inspection and Packaging department and plays a critical role in maintaining production schedules.**Essential Duties and Responsibilities**Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.* Manages creation, revision and development of documents, including the change control process, to achieve clear, concise and accurate instructional documents.* Provides editorial support and ensures quality of all document content; focuses on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines.* Initiate and manage document reviews and revision to achieve clear, concise, and accurate instructional documents.* Procure and distribute templates from Document Control for the generation of new documents.* Works and collaborates cross-functionally with other departments and sites to complete tasks and overall project timelines.* Identifies continuous improvement opportunities within the organization and effectively sees them through completion.* Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures, as well as cGMP requirements.* Perform tasks with a minimal error rate.* Perform any other tasks/duties as assigned by management.**Education Requirements and Qualifications**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.* High School Diploma or GED equivalent required.* 0-1 year of experience in manufacturing, inspection, packaging, document control, quality control and/or project management in a GMP setting preferred.* Strong computer and digital literacy including Microsoft Word and Excel products, required.* Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision.* Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.* Excellent organizational, time management, interpersonal and communication skills (oral and written).* Must be adaptable and able to switch priorities as needed.* Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.* Ability to take feedback constructively and consider the viewpoints of others.* Ability to work overtime as needed.**Physical Environment and Requirements*** Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves as required.
PPE and Respirators are essential for the health and safety of employees.* Employee must be able to occasionally lift and/or move up to 50 pounds.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.Applicants have rights under Federal Employment Laws.* FMLA poster:* Know Your Rights: )* Employee Polygraph Protection Act:**Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:**·
All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.·
Our recruiting process includes multiple in person and/or video interviews and assessments.·
If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com
before responding.·
We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make
accessible to any and all users.
If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities.
Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.
For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide. #J-18808-Ljbffr
New Albany, OHtime type:
Full timeposted on:
Posted Yesterdayjob requisition id:
R-103022**Nature and Scope** The Inspection and Packaging Document Control Coordinator I works with the Inspection and Packaging department in the activities associated with the Inspection and Packaging GMP documentation (Manufacturing SOPs, Manufacturing Batch records, protocols, reports, specifications, etc.) in accordance with company procedures and cGMPs. The Inspection and Packaging Document Control Coordinator I ensures work is completed in a timely manner and in accordance with company standards. The role plays a critical role in assuring safe, effective and compliant activities are performed in the Inspection and Packaging department and plays a critical role in maintaining production schedules.**Essential Duties and Responsibilities**Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.* Manages creation, revision and development of documents, including the change control process, to achieve clear, concise and accurate instructional documents.* Provides editorial support and ensures quality of all document content; focuses on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines.* Initiate and manage document reviews and revision to achieve clear, concise, and accurate instructional documents.* Procure and distribute templates from Document Control for the generation of new documents.* Works and collaborates cross-functionally with other departments and sites to complete tasks and overall project timelines.* Identifies continuous improvement opportunities within the organization and effectively sees them through completion.* Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures, as well as cGMP requirements.* Perform tasks with a minimal error rate.* Perform any other tasks/duties as assigned by management.**Education Requirements and Qualifications**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.* High School Diploma or GED equivalent required.* 0-1 year of experience in manufacturing, inspection, packaging, document control, quality control and/or project management in a GMP setting preferred.* Strong computer and digital literacy including Microsoft Word and Excel products, required.* Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision.* Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.* Excellent organizational, time management, interpersonal and communication skills (oral and written).* Must be adaptable and able to switch priorities as needed.* Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.* Ability to take feedback constructively and consider the viewpoints of others.* Ability to work overtime as needed.**Physical Environment and Requirements*** Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves as required.
PPE and Respirators are essential for the health and safety of employees.* Employee must be able to occasionally lift and/or move up to 50 pounds.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.Applicants have rights under Federal Employment Laws.* FMLA poster:* Know Your Rights: )* Employee Polygraph Protection Act:**Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:**·
All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.·
Our recruiting process includes multiple in person and/or video interviews and assessments.·
If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com
before responding.·
We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make
accessible to any and all users.
If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities.
Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer.
For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide. #J-18808-Ljbffr