-
GMP Compliance Investigator
1 week ago
Duke University Durham, United StatesSchool of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinici ...
-
IT Compliance Manager
1 week ago
CARsgen Therapeutics Durham, United States1. Responsibilities · 1. Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements. · 2. Responsible for the daily operation, troubleshooting, and maintenanc ...
-
GMP Compliance Investigator
1 week ago
Duke University Durham, United StatesSchool of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinici ...
-
cGMP Chemist
6 days ago
Piper Companies Durham, United StatesPiper Companies is currently seeking a cGMP Chemist for an opportunity in Durham, North Carolina (NC), to join a multinational pharmaceutical manufacturer bringing forward life-saving medications and vaccines. · Responsibilities of the cGMP Chemist Support commercial wet chemis ...
-
IT Compliance Manager
4 days ago
CARsgen Therapeutics Durham, United States1. Responsibilities · Remember to check your CV before applying Also, ensure you read through all the requirements related to this role. · 1. Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with ...
-
QA Compliance Manager
1 week ago
Cambrex Durham, United StatesOverview: · The QA Compliance Manager is responsible for the inspection readiness program for the assigned site. · Inspection readiness may include periodic internal audits, client audits, or any external agency · inspections like the FDA. Has the responsibility to lead audits ...
-
Procurement and Planning Manager
1 week ago
Accentuate Staffing Research Triangle Park, United StatesAccentuate Staffing is currently recruiting for a Procurement and Planning Manager for a medical device manufacturer in the RTP, NC area. This position will be responsible for management of external supplier relationships and ensuring the quality and timely delivery of components ...
-
Metals Post Processing Technician, 1st Shift
5 days ago
restor3d Durham, United StatesJob Description · Job DescriptionJob Summary: · The Manufacturing Technician position is responsible for the production and post-processing of medical devices including deburring, Mirror Polishing, media blasting, filing, cleaning, and packaging · 1st Shift – Mon – Fri, 6:00 am – ...
-
Environmental Technician, Water
5 days ago
Piper Companies Durham, NC, United States Full timePiper Companies is currently looking for an experienced Environmental Monitoring Technician in Durham, North Carolina (NC) to work for an innovative a leading pharmaceutical manufacturer. This Environmental Monitoring Technician will play an integral role in ensuring every single ...
-
Food Safety
5 days ago
Greene Resources Durham, United StatesPosition: Food Safety & Compliance Manager · Location: Henderson, NC · Pay: $70,000 to $90,000/yr (depending on experience) · Experience: · Three (3) to five (5) years of applicable experience · Prior supervisory experience · Education: Bachelor's degree from a regionally accred ...
-
Manufacturing Maintenance Tech 2
1 week ago
Biofire Diagnostics Durham, United StatesBenefits at bioMerieux: · Low-cost medical, dental, and vision benefits starting day one · 11 paid holidays · 160 hours of paid time off · Annual bonus · 9.5% 401k company contribution with no vesting period · Tuition reimbursement up to $10,000 per calendar year · Onsite cafeter ...
-
restor3d Durham, United StatesJob Description · Job DescriptionJob Summary: · The Polymers Post Processing will be responsible for the post-processing of 3D printed polymer devices. Relevant processes include: part washing, UV curing, support removal, and surface finishing. · Essential Duties and Responsibili ...
-
Specialist, Manufacturing Tech Support
6 days ago
Novartis AG Durham, United StatesSummary · Location: Durham, NC #onsite Relo statement: Novartis is unable to offer relocation support for this role. The Specialist, Manufacturing Technical Support, provides front line authority support for all process-specific issues to manufacturing, to ensure execution of pro ...
-
Manufacturing Maintenance Tech 2
5 days ago
bioMérieux Durham, United StatesWant to see more? Find all job opportunities for both BioFire and bioMérieux worldwide by clicking here. · Description · Benefits at bioMerieux:Low-cost medical, dental, and vision benefits starting day one11 paid holidays160 hours of paid time offAnnual bonus9.5% 401k company co ...
-
Manufacturing Maintenance Tech 2
3 days ago
bioMerieux Durham, United StatesBenefits at bioMerieux: · Low-cost medical, dental, and vision benefits starting day one · 11 paid holidays · 160 hours of paid time off · Annual bonus · 9.5% 401k company contribution with no vesting period · Tuition reimbursement up to $10,000 per calendar year · Onsite cafeter ...
-
Manufacturing Manager
1 day ago
Donaldson Durham, United StatesDonaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration an ...
-
Manufacturing Maintenance Tech 2
2 weeks ago
bioMerieux Durham, NC, United StatesBenefits at bioMerieux: · Low-cost medical, dental, and vision benefits starting day one · 11 paid holidays · 160 hours of paid time off · Annual bonus · 9.5% 401k company contribution with no vesting period · Tuition reimbursement up to $10,000 per calendar year · Onsite cafeter ...
-
Manufacturing Tech
1 week ago
Biofire Diagnostics Durham, United StatesBenefits at bioMerieux: · Low-cost medical, dental, and vision benefits starting day one. · 11 paid holidays · 160 hours of paid time off · Annual bonus · 9.5% 401k company contribution with no vesting period · Tuition reimbursement up to $10,000 per calendar year · Onsite cafete ...
-
QA Compliance Manager
1 week ago
Cambrex High Point Durham, United StatesCompany Information · You Matter to Cambrex. · Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and ...
-
Manufacturing Manager
3 days ago
Donaldson Durham, United StatesDonaldson is committed to solving the world's most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration an ...
Technical Writer V with FDA and GMP - Research Triangle Park, United States - DivIHN Integration Inc
Description
DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at
to learn more and view our open positions.Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Rashi at
Title: Technical Writer V (HYBRID)
Location: Research Triangle Park, NC
Duration: 16 Weeks
Proven experience as a technical writer, preferably in the pharmaceutical or biotechnology industry.
Description:
Possibility for Hybrid work arrangement but 2-3 days onsite will be required.
Position Overview
The Technical Writer, reporting to the Director of Facilities will be responsible for writing and developing Standard Operating Procedures (SOPs) and other process documents for the Facilities and Engineering (FandE) department. This position is eligible for hybrid or possibly fully remote work.
Responsibilities
Collaborate with subject matter experts (SMEs) within the Engineering Department to gather information and understand processes while translating workflows into procedures.
Write, revise, and coordinate the maintenance of SOPs, work instructions, training documents and other procedures in accordance with regulatory requirements and industry standards.
Ensure clarity, accuracy, and consistency in all documentation produced, adhering to company templates and guidelines.
Conduct thorough reviews of documents to ensure compliance with internal standards and stated goals and a coherent flow of information.
Work closely with cross-functional teams, including Quality Assurance, Laboratory Managers, and FandE management to gather feedback and incorporate changes as needed.
Education and Experience
Bachelor's degree in a scientific or engineering field or equivalent formal academic / vocational experience is required.
Proven experience as a technical writer, preferably in the pharmaceutical or biotechnology industry.
Familiarity with maintenance workflows, particularly as they relate to computerized maintenance management systems (CMMS).
Ability to translate processes and requirements into technical documentation.
Excellent writing, editing, and proofreading skills with keen attention to detail.
Strong understanding of regulatory requirements, including FDA and GMP.
Experience with process mapping and flowcharting tools.
Proficiency with document management systems and Microsoft Office Suite.
Strong communication and interpersonal skills with the ability to interact effectively with diverse stakeholders.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.