Technical Writer Job
Company Name:
Noramco, Inc. (6109)
Athens, GA, US
Technical Writer-7946140625
Description
Noramco, a member of Johnson & Johnson's Family of Companies, is recruiting for a Technical Writer, located in Athens, GA.
Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion Noramco is proud to be an equal opportunity employer.
The Technical Writer provides technical writing services and expedited guidance with computerized support systems (DocSpace, cApps, SAP) in support of technology transfer, new process introductions and the continuous improvement of operations and operations-related compliance activities for NORAMCO Athens, including validation and compliance with current Good Manufacturing Practices (cGMP). Responsibilites include: Reviews and composes technical reports and other sources of information to ensure that technical documentation and procedures are consistent with current industry, regulatory requirements and current technology. Compose process and cleaning validation protocols and reports for New Product Introduction into manufacturing facility. Write technical reports in support of customer inquiries. Create and maintain documentation such as master batch production records and key and controlled parameter documents. Prepare process and cleaning validation documents for new and existing processes. Ensure the timely preparation of reports in alignment with pre-determined timelines. Partner with Process Engineering, Laboratory, Planning, Scientific Affairs, Purchasing and Finance to produce documents. Interface with Quality Assurance, Scientific Affairs, Operations, and Quality Control to gain approvals. Execute necessary follow up services to ensure timely approval of required documents. Acts as specialist with various Business Systems (cApps, SAP, DocSpace) to facilitate NPI?s and validation activities. Initiate and coordinate SAP changes. Expedite cApps roles across Noramco sites and other Centers of Excellence to ensure critical path execution of projects. Partner with business owners to provide guidance regarding SAP technology, processes, and master data maintenance issues. Create, update, and maintain master data elements including Bill of Material and various production and costing versions. Liaise with other SAP specialists regarding master data configuration and maintenance issues. Follow master data maintenance procedures and standards. Manage master data and related change control process development and modification. Troubleshoot cApps and SAP system issues. Serves as a training liaison for departmental training requirements. May assist in training personnel on Business Systems and processes. Maintain knowledge of company procedures, products, systems, and processes to assure compliance with cGMP, regulatory and company standards. Assist Process Engineers with closure of CoC records. Support changes and validation of existing API manufacturing processes and intermediates. Participates in validation projects, programs and activities for the site. Investigates validation issues for equipment and/or performance processes and/or conducts equipment qualification activities. Provides guidance on aspects of validation and qualifications. Manage and coordinate multiple project priorities and work effectively across organization in completing projects on time. Strictly adhere to all project timelines and immediately raise issues that may delay these timelines to the supervisor. Serve on various committees and teams to enhance operations at the Noramco plant site as requested. (Audit preparation, 3 yr. document review).
Qualifications
Bachelor?s degree in chemistry, engineering or other related pure science is required; Minimum of 2 years of technical writing experience in a highly regulated and proceduralized manufacturing environment required; Experience in a cGMP regulated environment is highly preferred; Previous work experience with SAP, Electronic Document Management Systems, and Electronic Event Tracking Systems required; Teaching level knowledge is highly preferred; Excellent verbal and written communication and interpersonal skills is required; Previous Project Management experience is preferred; Proficient with Microsoft Office required; Proven ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations required; Experience with Minitab, Visio, SAP, DocSpace, and Trackwise preferred; Ability to influence and collaborate with cross-functional teams and multiple stakeholders at various levels of the organization required; Ability to work with others in a team environment, but can also work independently with minimal supervision required; Proven ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production required; Ability to perform under stress in cases of emergency, critical or hazardous situations required; Proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment preferred; Familiarity with inter-relationships between all regulatory environmental, safety, GMP, ISO and training requirements required; Strong technical and troubleshooting skills as demonstrated through prior performance achievements required; Able to manage multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities required; Ability to apply risk management philosophy to business processes, decisions and data required; Ability to negotiate and resolve conflicts effectively required. As dictated by the essential functions and responsibilities of this position, the individual must be capable of moving around the plant to perform on-site investigations; As dictated by the essential functions and responsibilities of this position, the individual is occasionally required to climb or balance (stairs/ladders); stoop, kneel, crouch, or crawl; and smell; Must be available for overtime work on a scheduled or emergency basis; Limited travel required.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:
North America-United States-Georgia-Athens
Organization:
Noramco, Inc. (6109)
Job Function:
Validation
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
Noramco, Inc. (6109)
Athens, GA, US
Technical Writer-7946140625
Description
Noramco, a member of Johnson & Johnson's Family of Companies, is recruiting for a Technical Writer, located in Athens, GA.
Noramco, Inc. produces a variety of active pharmaceutical ingredients and is a major worldwide producer of medicinal analgesics, pharmaceutical intermediates and synthetic fine organic chemicals. It also produces monomers and polymers for pharmaceutical and medical devices.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion Noramco is proud to be an equal opportunity employer.
The Technical Writer provides technical writing services and expedited guidance with computerized support systems (DocSpace, cApps, SAP) in support of technology transfer, new process introductions and the continuous improvement of operations and operations-related compliance activities for NORAMCO Athens, including validation and compliance with current Good Manufacturing Practices (cGMP). Responsibilites include: Reviews and composes technical reports and other sources of information to ensure that technical documentation and procedures are consistent with current industry, regulatory requirements and current technology. Compose process and cleaning validation protocols and reports for New Product Introduction into manufacturing facility. Write technical reports in support of customer inquiries. Create and maintain documentation such as master batch production records and key and controlled parameter documents. Prepare process and cleaning validation documents for new and existing processes. Ensure the timely preparation of reports in alignment with pre-determined timelines. Partner with Process Engineering, Laboratory, Planning, Scientific Affairs, Purchasing and Finance to produce documents. Interface with Quality Assurance, Scientific Affairs, Operations, and Quality Control to gain approvals. Execute necessary follow up services to ensure timely approval of required documents. Acts as specialist with various Business Systems (cApps, SAP, DocSpace) to facilitate NPI?s and validation activities. Initiate and coordinate SAP changes. Expedite cApps roles across Noramco sites and other Centers of Excellence to ensure critical path execution of projects. Partner with business owners to provide guidance regarding SAP technology, processes, and master data maintenance issues. Create, update, and maintain master data elements including Bill of Material and various production and costing versions. Liaise with other SAP specialists regarding master data configuration and maintenance issues. Follow master data maintenance procedures and standards. Manage master data and related change control process development and modification. Troubleshoot cApps and SAP system issues. Serves as a training liaison for departmental training requirements. May assist in training personnel on Business Systems and processes. Maintain knowledge of company procedures, products, systems, and processes to assure compliance with cGMP, regulatory and company standards. Assist Process Engineers with closure of CoC records. Support changes and validation of existing API manufacturing processes and intermediates. Participates in validation projects, programs and activities for the site. Investigates validation issues for equipment and/or performance processes and/or conducts equipment qualification activities. Provides guidance on aspects of validation and qualifications. Manage and coordinate multiple project priorities and work effectively across organization in completing projects on time. Strictly adhere to all project timelines and immediately raise issues that may delay these timelines to the supervisor. Serve on various committees and teams to enhance operations at the Noramco plant site as requested. (Audit preparation, 3 yr. document review).
Qualifications
Bachelor?s degree in chemistry, engineering or other related pure science is required; Minimum of 2 years of technical writing experience in a highly regulated and proceduralized manufacturing environment required; Experience in a cGMP regulated environment is highly preferred; Previous work experience with SAP, Electronic Document Management Systems, and Electronic Event Tracking Systems required; Teaching level knowledge is highly preferred; Excellent verbal and written communication and interpersonal skills is required; Previous Project Management experience is preferred; Proficient with Microsoft Office required; Proven ability to effectively use software applications for data entry, data analysis, word processing, presentations, and calculations required; Experience with Minitab, Visio, SAP, DocSpace, and Trackwise preferred; Ability to influence and collaborate with cross-functional teams and multiple stakeholders at various levels of the organization required; Ability to work with others in a team environment, but can also work independently with minimal supervision required; Proven ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production required; Ability to perform under stress in cases of emergency, critical or hazardous situations required; Proficient knowledge of cGMPs, safety and environmental regulations as they apply to a pharmaceutical or chemical manufacturing environment preferred; Familiarity with inter-relationships between all regulatory environmental, safety, GMP, ISO and training requirements required; Strong technical and troubleshooting skills as demonstrated through prior performance achievements required; Able to manage multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities required; Ability to apply risk management philosophy to business processes, decisions and data required; Ability to negotiate and resolve conflicts effectively required. As dictated by the essential functions and responsibilities of this position, the individual must be capable of moving around the plant to perform on-site investigations; As dictated by the essential functions and responsibilities of this position, the individual is occasionally required to climb or balance (stairs/ladders); stoop, kneel, crouch, or crawl; and smell; Must be available for overtime work on a scheduled or emergency basis; Limited travel required.
BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:
North America-United States-Georgia-Athens
Organization:
Noramco, Inc. (6109)
Job Function:
Validation
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
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