GMP Technical Writer

POSITION TITLE: GMP Technical Writer

REPORT TO:  Senior Director of Quality & Regulatory

POSITION SUMMARY:

The GMP Technical Writer is responsible for directly participating in a Quality Systems Integration Program, with primary responsibility being the creation of high-quality content. The GMP Technical Writer will be assisting the Senior Director of Quality Assurance & Regulatory Affairs.

PRINCIPAL DUTIES:

• Assist the Senior Director of Quality & Regulatory Affairs in the preparation of Quality and Regulatory documents.
• Directly participate in a Quality Systems Integration Program, with the primary responsibility being the creation of high-quality written content.
• Daily interaction with technical documentation, with documentation tasks to be performed with quantitated high-throughput and attention to detail.
• Required to proofread, prepare, create, review, edit, and update Quality and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Client Requirements, Product Requirements, Design Outputs, Design Verification Protocol and Reports), Technical Reports, Manufacturing Processes, Product Release, Materials Management, Quality Incidents, Complaint Handling, & CAPAs.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships.
• Maintain a comprehensive library of technical terminology and documentation.
• Carries out duties in compliance with established business policies.

• Adapt rapidly to a changing industry and be able to adjust responsibilities, time, and objectives accordingly.
• Perform other duties & projects as assigned.

MINIMUM QUALIFICATIONS/REQUIREMENTS:

• Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology, or related scientific discipline (Biomedical Engineering, or other related engineering field) or related field, or equivalent combination of education and work-related experience.
• 3-5 years of experience of technical writing experience in a GMP, Biotechnology, Pharmaceuticals, or another Regulated Industry.
• Experience with MS Office Products required.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience) required.
• Flexible, with ability to work effectively in a fast-paced, dynamic environment with shifting and competing demands is required.

To apply for this position, please email your resume with cover letter to info@pyramidlabs.com .

ABOUT PYRAMID:

PYRAMID Laboratories, Inc. (PYRAMID), established in 1988, is a rapidly growing contract manufacturing organization located in Costa Mesa, CA, USA. Our facilities are housed in three (3) buildings covering approximately 90,000 sq. ft. Our leading-edge manufacturing facilities allow PYRAMID to offer the pharmaceutical and biotech industries a wide range of services including aseptic vial and syringe filling, as well as lyophilization capabilities, for both Clinical and Commercial products. Over the years, PYRAMID has established a reputation for performance, professional integrity, and quality services. You can view our website at https://www.pyramidlabs.com. PYRAMID is an Equal Opportunity Employer. PYRAMID provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.