PSC Biotech Corporation ยท 2 days ago
Technical Writer
United States
Full-time
Remote
Mid Level
3+ years exp
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Responsibilities
Support all technical writing projects in collaboration with the operations teams.
Write, review, and revise quality assurance and operations documents, protocols, preports, and analytical method qualification documentation.
Work closely with quality and manufacturing teams to develop technical specifications for products or systems.
Determine and plan technical report requirements and ensure, through research, that the technical report will fulfill the intended use.
Able to analyze existing technical material for reuse and leveraging of information to include in documentation.
Maintain industry standards, following cGMP and GDP guidelines and protocols. Maintain standardized and consistent documentation practices.
Establish and support documentation practices that reduce review times and deviation by researching errors and inconsistencies in existing records and communicating effectively with appropriate personnel.
Identify and support process improvement efforts (root cause analysis/investigations/corrective actions/etc.).
Assist in editing documentation written by others to verify accuracy, consistency, grammar, and format.
Communicate and collaborate with team members and project staff to plan, develop, and produce high-quality communication products in a fast-paced environment.
Qualification
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Required
Strong knowledge of FDA regulations and IND (Investigational New Drug) applications.
3-10 years of experience in technical writing, preferably in the life sciences industry.
Proven ability to write clear, concise, and accurate technical documentation.
Strong technical background and experience. Solid understanding of quality principles, terminology, processes, and concepts.
Advanced cGMP knowledge and ability to maintain documentation standards.
Excellent communication skills - verbal and written. Ability to collaborate with cross-functional teams.
Excellent attention to detail.
Strong organizational skills with the ability to multi-task and manage multiple documentation projects.
Strong analytical and problem-solving skills. Adaptable, proactive learner.
Benefits
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more).
Financial Perks and Discounts
Company
PSC Biotech Corporation
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
John Clapham
Founder, President & CEO
Company data provided by crunchbase
