Technical Writer

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special.

When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech, it’s about more than just a job it’s about your career and your future. Your Role We are hiring detail-oriented and motivated Technical Writer to join our team.

• Responsible for writing clear, accurate, and compliant protocols and reports for the transfer of analytical test methods.
• Collaborate with subject matter experts (SMEs) and cross functional teams to gather and verify technical information, ensuring the accuracy and completeness of documentation.
• Create and update test specification documents for raw materials and finished products.
• Assist in drafting analytical procedures.
• Review and manage technical documents for approval in the electronic document management system (eDMS).
• Prepare and design comparative studies and development studies for analytical testing.
• Identify opportunities for process improvements and contribute to the development and maintenance of documentation best practices.
• Support various project activities in the analytical lab as needed, ensuring readiness for testing or studies.
• Stay up-to-date with industry regulations and guidelines (e.g., FDA, EMA) to ensure that all documentation meets regulatory requirements and contributes to regulatory submissions.
• Additional requirements as assigned.

Requirements

• 3+ years of technical writing and documentation experience in a cGMP environment.
• Excellent technical writing and documentation skills.
• Experience with analytical procedures and test methods.
• Strong knowledge of cGMP regulations.
• Proficiency with electronic document management systems.
• Excellent communication skills both verbal and written with the ability to convey complex technical information in a clear and concise manner.
• Attention to detail and a commitment to producing error-free documentation.
• Highly motivated with the ability to work independently, manage multiple projects, and meet deadlines.
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements.

The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.

Benefits

Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success.

We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

• 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

Equal Opportunity Employment Statement : PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.

Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination.

Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to : recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs.

Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived : race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.#LI-RW1