• Support all DQP project implementation tasks. 
• Develop and maintain comprehensive documentation. Author document templates to guide the creation of future equipment procedures and forms.
• Support all technical writing requirements including but not limited to SOPs for analytical equipment and systems, calibration, qualification, and maintenance. 
• Collaborate with laboratory personnel to ensure proper calibration, validation, and functionality of analytical instruments.
• Author and review instrument procedures. 
• Develop equipment binders.
• Work closely with third party vendors, scheduling equipment qualifications for remediation work. 
• Implement user access controls and audit trails.
• Update equipment maintenance system to include information required per DQP implementation project. 
• Ensure effective communication and frequent reports with team members and stakeholders regarding all project/deliverable progress, issues, risks, upcoming requirements, and so on. 
• Attend weekly project meetings as needed.
• Identify opportunities for process improvement within the non-GMP labs and contribute to the implementation of best practices.
• Ensure adherence to regulatory requirements and internal quality standards.

Requirements

• Bachelor's degree in engineering or related technical field. 
• Minimum of 3 years of engineering and technical writing experience with analytical equipment. 
• Must possess knowledge of USP 1058.
• Excellent technical writing skills.
• Must have extensive experience with analytical equipment and systems.
• Experience writing operating procedures for analytical equipment including calibration, qualification, and maintenance. 
• ​Strong understanding of regulatory requirements.
• Ability to work independently and manage daily activities in order to drive project completion and success. 
• Excellent communication and coordination skills. 
• Strong time-management with the ability to meet tight deadlines. 
• Flexible - willing to work overtime when required. 
• 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

• 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
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

Job Summary