- Management of Technical Documentation
- Work cross-functionally and collaboratively with trial coordinators, scientists, engineering, operations, Global Sourcing and Global QA, influencing as needed.
- Conduct statistical analysis of data from trials and on-going manufacturing upgrades and improvements.
- Draw conclusions from statistical analysis of Research Special Run (RSR) & Manufacturing Special Run (MSR) trials, and manufacturing data
- Create or edit TIS and TDS based on conclusions drawn.
- Coordinate revision control for Technical Information Sheets (TIS), Technical Data Sheets (TDS), Manufacturing Specs and other related documents.
- Propose, develop, and maintain an efficient and accurate process for gathering technical information to be incorporated into Agile system.
- With Global Regulatory Team, document regulatory and product stewardship requirements of all global product categories and global related systems. (EPA, FDA, BPR, TGA, MoCRA, RSPO, RSCO and CMS customer)
- Subject matter expert (SME) of Global Systems (each system has different compliance and specific formatting required). Provide training to GPD, GQA and Regulatory Affairs, both internal and external, on relevant customer and regulatory systems in the areas of procedures, policies and compliance or technical and related documentation.
- Demonstrate commitment to Rockline's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
- Four-year college degree in a science, engineering, or IT related discipline preferred.
- 5+ years' experience working in technical documentation methods and processes.
- Technical writing experience required.
- Experience with data and statistical analysis required.
- Formal documentation process within the U.S. and specific countries – currently, Mexico, UK Australia and New Zealand or regions preferred.
- Must have ability to work independently and within different time zones.
- Ability to travel internationally.
- Excellent attention to detail and accuracy.
- Technical communication skills.
- Must be able to use standard MS Office products and work within JDE Agile and PLM.
-
Document Control Specialist
hace 3 días
Harman International MéxicoA Career at HARMAN · As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you'll disco ...
-
Document Specialist I
hace 1 semana
Fortrea Ciudad de MéxicoClinical Document Specialist I - Remote · Are you looking for a fresh start within a clinical document environment? Interested in working within Clinical Pharmacology, working alongside our Project Management and Phase I Monitoring team, in an administrative and IT-focused opport ...
-
Document Control Specialist
hace 1 semana
Underwriters Laboratories Inc. México: · At UL, we know why we come to work.: · Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. ...
-
Quality Specialist Document Mgt&art Work
hace 4 horas
Sandoz Ciudad de México1996 In this year Sandoz initiated the world's first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization ...
-
Document Specialist I
hace 2 días
Fortrea Tlahuac, MéxicoAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
-
Document Specialist I
hace 6 días
Fortrea Mexico City, México De jornada completaAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and techn ...
-
Document Control Specialist I
hace 1 semana
Aecom MéxicoCompany DescriptionWork with Us. Change the World.At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted ...
-
Especialista en Soporte de Operaciones
hace 1 día
Citi Ciudad de MéxicoThe Ops Support Specialist 4 is an entry-level position responsible for providing operations support services, including but not limited to; record/documentation maintenance, storage & retrieval of records, account maintenance, imaging and the opening of accounts in coordination ...
-
Analista de Estados de Cuenta
hace 6 días
Citi Ciudad de MéxicoThe Ops Support Specialist 4 is an entry-level position responsible for providing operations support services, including but not limited to; record/documentation maintenance, storage & retrieval of records, account maintenance, imaging and the opening of accounts in coordination ...
-
Analista de Validación de Estados de Cuenta
hace 1 semana
Citi Ciudad de MéxicoThe Ops Support Specialist 3 is an entry-level position responsible for providing operations support services, including but not limited to; record/documentation maintenance, storage & retrieval of records, account maintenance, imaging and the opening of accounts in coordination ...
-
Accounts Payable Specialist
hace 3 días
Solera City, MéxicoAccounts Payable Specialist / Mexico · Who We Are · The Role · Solera is seeking a detail-oriented and organized Accounts Payable Specialist to join our finance team. The Accounts Payable Specialist will play a crucial role in ensuring accurate and timely processing of invoices, ...
-
Change Coordinator Tpm
hace 1 semana
DRÄXLMAIER Group MéxicoModern wire harness systems and exclusive vehicle interiors: The name DRAEXLMAIER stands for automotive innovations - products that enhance your driving experience. Every day, approximately 75,000 associates around the world cooperate to contribute their knowledge, skills and aut ...
-
Accounts Payable Specialist
hace 1 día
Solera City, MéxicoAccounts Payable Specialist / Mexico · Who We Are · The Role · Solera is seeking a detail-oriented and organized Accounts Payable Specialist to join our finance team. The Accounts Payable Specialist will play a crucial role in ensuring accurate and timely processing of invoices, ...
-
Project Coordinator Cps
hace 1 semana
Fortrea Ciudad de MéxicoThe statements below reflect the general responsibilities and requirements of the identified position but may not describe all the work requirements that may be inherent in the job. It is the responsibility of all employees to comply with all applicable regulations [e.g., Good Cl ...
-
HR Info System Analyst-experienced
hace 2 días
Eastman México**Responsibilities**: · - We are looking for a HR Specialist who will work with the Eastman team on the initial implementation of the SuccessFactors Talent Management modules, including Onboarding and Succession & Development. · - Under the guidance of the HR Systems Manager, ass ...
-
Intake Specialist
hace 6 días
Novartis Ciudad de México392364BR · **Intake Specialist**: · Mexico · **About the role** · Novartis Corporate Center Mexico City is one of six strategically located corporate centers established by Novartis globally. Novartis Corporate Center Mexico City is one of six strategically located corporate cent ...
-
Accounts Receivable Billing Specialist Iii
hace 1 semana
Solera City, MéxicoThe Role · - The Billing Specialist Level 3 plays a pivotal role within the Accounts Receivable department, focused on managing billing processes, ensuring the accurate and timely creation of invoices, and addressing billing-related inquiries. This position is crucial in maintain ...
-
Heor Modelling Specialist
hace 1 semana
Johnson & Johnson Ciudad de México**HEOR MODELING SPECIALIST - MEXICO & CENCA** · At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with sc ...
-
Configuration & Qc Specialist I
hace 1 semana
ICON Ciudad de MéxicoAt ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives. · ICON plc is a world-leading healthcare intelligence and clinical research organization. ...
-
Procurement Analyst
hace 2 días
Clip Ciudad de México**Purpose of the Job**: · We are looking for a** Procurement Analyst** to be part of this amazing Fintech and the Finance team. She / He will be responsible for vendor onboarding processes, validating, communicating, and auditing supplier information, documenting the process, too ...
GPD Technical Documentation Specialist - México - Rockline Industries, Inc.
Descripción
Tech Center, Springdale, AR
Springdale, AR 72764, USA
Join our dynamic team as a Global Product Development Technical Documentation Specialist As the mastermind behind Technical Information Sheets (TIS), Technical Data Sheets (TDS), and Manufacturing Specs, you'll collaborate cross-functionally to ensure alignment with regulatory standards and customer requirements. In this role, your drive planning, creating, implementing, and controlling specific technical documentation that drives and aligns with Rockline, government, and customer business procedures, policies, and practices.
ESSENTIAL ACCOUNTABILITIES:
QUALIFICATION REQUIREMENTS:
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
#J-18808-Ljbffr