Technical Writer I-Senior
Technical Writer I-Senior
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Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
The Technical Writer (I II III and Senior) provides Manufacturing support Manufacturing operations by planning collaborating and implementing timelines to generate and maintain GMP documents related to GMP operations while ensuring compliance with established processes and standards.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES I/II
- Write and revise GMP documentation including but not limited to: Standard Operating Procedures (SOPs) Work Instructions (WOIs) and Manufacturing Production Records (MPRs).
- Facilitate cross functional and collaborative discussion regarding technical writing tasks for the Manufacturing Department.
- Ensure collaboration among applicable departments (e.g. Manufacturing Quality Control MSAT etc. as it applies to technical writing.
- Maintain Good Documentation Practices (GDP) including company error prevention practices for document management.
- Communicate statuses risks and timelines effectively to management.
- Follow and adhere to company policies and procedures.
- Maintain templates trackers and metrics for documents and projects.
- Develop a strong understanding of the manufacturing process and product.
- Maintain on time training qualification in accordance with company policies.
- Act as a technical writing representative between departments and for client interactions
- Maintain safe work environment.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES III/Senior
- All essential job duties applicable to the Technical Writer I/II Manufacturing position.
- Facilitate cross functional and client facing discussions regarding general technical writing tasks as well as critical process updates as applicable.
- Participate in technical client facing meetings and communicate outcomes to prioritize project changes and drive strategic implementation.
- Manage complex projects or improvement initiatives as it relates to manufacturing technical writing including but not limited to training new employee onboarding tracking tools etc.
TECHNICAL KNOWLEDGE & LEADERSHIP SKILLS
- Ability to apply GMP requirements as they relate to manufacturing operations and quality management systems
- Demonstrate experience with technical writing and GMP documentation
- Experience with managing and progressing multiple priorities
- Ability to work interdepartmentally effectively with good interpersonal skills
- Strong technical writing and communication skills
- Strong computer literacy required (e.g. MS Office Suite etc.
EDUCATION & EXPERIENCE
- BS in scientific discipline such as Biochemistry Chemistry Biology or related discipline preferred.
- Experience using quality management systems software (e.g. TrackWise) preferred.
- Equivalent education and experience may substitute for stated requirements.
- Levels have different requirements these are listed as follows:
Technical Writer I Manufacturing
- 0 to 2 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
Technical Writer II Manufacturing
- Minimum 1 to 4 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
Technical Writer III Manufacturing
- Minimum of 5 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
Technical Writer Senior Manufacturing
- Minimum of 8 years of experience in quality management systems and/or pharmaceutical manufacturing environment in a regulated or GMP environment.
COMPENSATION RANGE
$25.65 $49.55 depending on level and experience
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visitwww.agcbio.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Employment Type
Full-Time
