Technical Writer

2 weeks ago

Marietta, United States eTeam Full time

Position Title: Technical Writer

Duration: 1 Year (potential for extension up to 18 months)

Location: Marietta, PA

100% ON SITE: Monday to Friday, day shift (8 hours/day).

Pay Rate: $46.06/hr on W2 All Inclusive without benefits


JOB PURPOSE:

• Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business processes, SOPs, batch records, checklists, etc.)

• Serve as liaison between manufacturing groups, as well as between manufacturing and support departments, to ensure accurate, compliant and streamlined controlled documents.

• Drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.

• Champion standardization of documents across groups within manufacturing (e.g., content, structure, format, etc.)

• Serve as a change coordinator for projects in the manufacturing department.

• Partner with learning and development as well as Manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competency.


KEY RESPONSIBILITIES:

Environmental Health & Safety:

Promote a highly safety-conscious culture and EHS-focused workforce. Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice.


Quality & Compliance: Support integration of overarching Manufacturing systems and procedures to achieve inspection readiness at all times. Ensure all activities are executed following quality and regulatory standards. Support implementation and monitoring of quality systems to achieve inspection readiness at all times. Promote a quality mindset and quality excellence approach to all activities. Adhere to all Client Quality Management System (QMS) policies and procedures as applicable.

• Format and manage documents using appropriate guidelines and established document templates.

• Evaluate GMP documentation change requests to determine scope of change, and ensure accurate information in revision history (associated CAPAs, Change Controls, Impact Assessments, etc.)

• Where appropriate, manage CAPA tasks related to GMP documentation revisions.

• Determine when GMP documentation duplications exist and manage resolution and consolidation of affected documents.


Continuous Improvement:

Support Lean/Six Sigma program to drive and embed a culture of continuous improvement by the use of operational excellence methodologies to realize ever-increasing levels of value in the usability and practicality of documents;

• Partner with local Learning and Development team to drive the revision and creation of SOPs and GMP documents that enable effective training, retention of information and competency.

• Partner with Pn MAPS manufacturing team to drive the revision and creation of business processes enable effective training, retention of information and competency.

• Incorporate revisions and ensure consistent terminology and language for presentation of information.

• Partner with key stakeholders and drive continuous improvement in the controlled document system and determine best practices that increase usability and practicality of documents.


Accountability:

• Partner with LSOP Process Owners, to obtain accurate content for inclusion in documents, utilizing shop floor Gembas and process walk-downs, to drive inclusion of effective and accurate content in documents, and communicate significant GMP documentation changes in procedures to process owners.

• Partner with Doc Adnims to ensure documents are submitted for upload into eSOP in an accurate, timely manner.

• Monitor document cycle time and escalate overdue tasks as required.


Change Management:

Deal positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves. Positively influence others’ ability to adapt to change.


EDUCATION REQUIREMENTS:

Bachelor’s or higher degree. MAPS production is a novel vaccine process which requires a scientific background. Practical experience in the biopharmaceutical industry is required given the highly regulated safety and quality standards.


• Knowledge of cGMP, FDA and other regulatory requirements and quality systems

• Working knowledge of SAP with demonstrated ability to learn other facets of SAP (i.e. eSOP, and change control)

• Proficient use of MS Office Suite, Visio, digital imaging


PREFERRED LEVEL OF EDUCATION:

Technical Writing degree or specialized training in technical writing. MAPS production is a novel vaccine process which requires a scientific background. Practical experience in the biopharmaceutical industry is required given the highly regulated safety and quality standards.


• Knowledge of cGMP, FDA and other regulatory requirements and quality systems

• Working knowledge of SAP and MES eBR with demonstrated ability to learn other facets of SAP and MES (i.e. eSOP, eBR, eChecklist and change control). Proficient use of MS Office Suite, Visio, Arris, digital imaging


MINIMUM LEVEL OF JOB-RELATED EXPERIENCE REQUIRED:

To effectively coordinate the efforts of production and supervisory staff to achieve manufacturing objectives and milestones. Demonstrated ability in the following:

• Ability to prioritize and flexibility to adapt to changing business schedules and deadlines

• Ability to coordinate projects involving multiple documents and clients

• Good communication, organizational and team skills

• Public speaking/presentation

• Ability to take initiative and work proactively with creative problem-solving skills

• Demonstrated experience driving change and delivering results with a strong commitment to individual accountability for tasks

• Strong interpersonal communication skills and ability to thrive in a dynamic team environment

• Capable of working without direct supervision

Committed team player prepared to work in and embrace a team-based culture

  • Technical Writer

    1 week ago

    Marietta, Pennsylvania, United States eTeam Full time

    Job Title: Technical WriterWe are seeking a skilled Technical Writer to join our team at eTeam. As a Technical Writer, you will be responsible for creating, revising, and improving documents within our manufacturing department.Key Responsibilities:Author and maintain technical documents, including business processes, SOPs, batch records, checklists, and...

  • Biopharmaceutical Technical Writer

    4 days ago

    Marietta, Pennsylvania, United States The Accuro Group Full time

    Job Title: Technical WriterLocation: Marietta, PAJob Type: ContractDuration: 3 MonthsJob Description:We are seeking a highly skilled Technical Writer to join our team at The Accuro Group. As a Technical Writer, you will play a crucial role in promoting a safety-conscious culture and EHS-focused workforce.Key Responsibilities:Promote a highly safety-conscious...

  • Biopharmaceutical Technical Writer

    5 days ago

    Marietta, Pennsylvania, United States The Accuro Group Full time

    Job Title: Biopharmaceutical Technical WriterAbout the Role:The Accuro Group is seeking a skilled Biopharmaceutical Technical Writer to join our team. As a Technical Writer, you will be responsible for authoring, revising, and improving documents within manufacturing. This includes business processes, SOPs, batch records, checklists, and other controlled...

  • Biopharmaceutical Technical Writer Specialist

    1 week ago

    Marietta, Pennsylvania, United States The Accuro Group Full time

    Job Title: Technical WriterWe are seeking a highly skilled Technical Writer to join our team at The Accuro Group.Job Summary:The successful candidate will be responsible for promoting a highly safety-conscious culture and EHS-focused workforce.Key Responsibilities:Develop and implement effective communication strategies to promote a safety-first...

  • Biopharmaceutical Technical Writer

    3 weeks ago

    Marietta, United States The Accuro Group Full time

    Business Title: 104308 | Technical Writer Location: Marietta, PA 17547 Job Type: Contract (3 M) Job Description: Promote a highly safety conscious culture and EHS focused workforce. Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice. Job Responsibilities: Serve as a Technical...

  • Technical Writer

    2 weeks ago

    Marietta, United States eTeam Full time

    Position Title: Technical WriterDuration: 1 Year (potential for extension up to 18 months)Location: Marietta, PA100% ON SITE: Monday to Friday, day shift (8 hours/day).Pay Rate: $46.06/hr on W2 All Inclusive without benefitsJOB PURPOSE:• Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business...

  • Manufacturing Technical Writer

    3 weeks ago

    Marietta, Pennsylvania, United States eTeam Full time

    About the RoleWe are seeking a highly skilled Manufacturing Technical Writer to join our team at eTeam. As a key member of our manufacturing department, you will be responsible for creating, revising, and improving documents related to manufacturing processes, business processes, and quality systems.Key ResponsibilitiesDocument Control: Ensure accurate and...

  • Manufacturing Technical Writer

    3 weeks ago

    Marietta, United States eTeam Full time

    Position Title: Technical WriterDuration: 1 Year (potential for extension up to 18 months)100% ON SITE: Monday to Friday, day shift (8 hours/day).Pay Rate: $46.06/hr on W2 All Inclusive without benefitsJOB PURPOSE:• Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business processes, SOPs, batch...

  • Technical Writer

    3 weeks ago

    Marietta, United States Randstad Life Sciences Full time

    Job DescriptionJob DescriptionJob Details:Technical Writer in Marietta, PA1 Year (potential for extension)Shift: Monday-Friday 8:00 am-5:00 pm. - 100% ONSITE Required:• Bachelor’s or higher degree. MAPS production is a novel vaccine process that requires a scientific background. Practical experience in the biopharmaceutical industry is required given...

  • Manufacturing Technical Writer

    1 week ago

    Marietta, United States eTeam Full time

    Position Title: Technical WriterDuration: 1 Year (potential for extension up to 18 months)100% ON SITE: Monday to Friday, day shift (8 hours/day).Pay Rate: $46.06/hr on W2 All Inclusive without benefitsJOB PURPOSE:• Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business processes, SOPs, batch...

  • Quality Assurance Technical Writer

    2 weeks ago

    Marietta, Pennsylvania, United States LanceSoft, Inc. Full time

    Job SummaryLanceSoft, Inc. is seeking a highly skilled Quality Assurance Technical Writer to join our team. As a key member of our manufacturing department, you will be responsible for creating, revising, and improving documents related to business processes, SOPs, batch records, checklists, and more.Key ResponsibilitiesDocument Creation and Revision:...

  • Technical Writer

    3 weeks ago

    Marietta, United States Randstad Life Sciences US Full time

    Job Details:Technical Writer in Marietta, PA1 Year (potential for extension)Shift: Monday-Friday 8:00 am-5:00 pm. - 100% ONSITERequired:• Bachelor’s or higher degree. MAPS production is a novel vaccine process that requires a scientific background. Practical experience in the biopharmaceutical industry is required given the highly regulated safety and...

  • Technical Writer

    3 weeks ago

    Marietta, United States Randstad Life Sciences US Full time

    Job Details:Technical Writer in Marietta, PA1 Year (potential for extension)Shift: Monday-Friday 8:00 am-5:00 pm. - 100% ONSITERequired:• Bachelor’s or higher degree. MAPS production is a novel vaccine process that requires a scientific background. Practical experience in the biopharmaceutical industry is required given the highly regulated safety and...

  • Quality Assurance Technical Writer

    2 weeks ago

    Marietta, United States LanceSoft, Inc. Full time

    Description: POSITION TITLE: Technical Writer DURATION: 1 Year (potential for extension up to 18 months) 100% ON SITE: Monday to Friday, day shift (8 hours/day). JOB PURPOSE: • Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business processes, SOPs, batch records, checklists, etc.) • Serve...

  • Quality Assurance Technical Writer

    3 weeks ago

    Marietta, United States LanceSoft, Inc. Full time

    Description: POSITION TITLE: Technical Writer DURATION: 1 Year (potential for extension up to 18 months) 100% ON SITE: Monday to Friday, day shift (8 hours/day). JOB PURPOSE: • Serve as a Technical Writer dedicated to authoring, revising and improving documents within manufacturing. (Business processes, SOPs, batch records, checklists, etc.) • Serve...

  • Biopharmaceutical Technical Writer

    2 weeks ago

    Marietta, Pennsylvania, United States The Accuro Group Full time

    About The Accuro GroupWe are a leading provider of specialized services to the biopharmaceutical industry.Job SummaryWe are seeking a highly skilled Technical Writer to join our team on a contract basis. The successful candidate will be responsible for promoting a safety-conscious culture and EHS-focused workforce.Key ResponsibilitiesDevelop and Implement...

  • Biopharmaceutical Technical Writer

    2 weeks ago

    Marietta, Pennsylvania, United States The Accuro Group Full time

    Job SummaryWe are seeking a highly skilled Biopharmaceutical Technical Writer to join our team at The Accuro Group. As a key member of our organization, you will be responsible for creating, revising, and improving documents within our manufacturing department.Key ResponsibilitiesDevelop and maintain high-quality documents, including business processes,...

  • Quality Assurance Specialist

    3 weeks ago

    Marietta, United States Accuro Full time

    Business Title: Technical WriterLocation: Marietta, PAJob Type: 3+ months contract Promote a highly safety conscious culture and EHS focused workforce. Perform all job responsibilities in compliance with applicable regulations, current operating procedures, and industry practice. Job Responsibilities: Serve as a Technical Writer dedicated to authoring,...