Technical Document Writer - Biomanufacturing

Technical Document Writer - Biomanufacturing

Contract

Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

• We are currently looking for a cGMP Technical Writer who will be responsible for writing, reviewing and driving production and quality documentation to approval.
• The Technical Document Writer will be responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals.
• Additional responsibilities might include tracking the daily, weekly and monthly forecasted documentation priorities required to meet output quotas.

• Originate, revise and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records.
• Compile and draft procedural documentation using standard electronic publishing tools.
• Create and maintain templates for cGMP documents.
• Collaborate with individuals from various internal functional areas to generate and review new equipment, processing, set-up and operational documents within agreed upon timelines.
• Interview subject matter experts to obtain details in order to accurately capture content material.
• Demonstrate effective written and verbal communication skills.
• Monitor the flow of production documents and adjust workload and resources in an appropriate, organized and efficient manner.
• Work with cross-functional teams on the implementation of process improvement initiatives to increase quality in cGMP documentation.
• Demonstrate an ability to multi-task and manage multiple projects independently.
• Maintain a safe work environment for self and staff.

• Aware of and comply with the client Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Aware of and comply with Stop Order, Concessions, ESD ECO, Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices, as associated with this job type/position.

Training:
Aware of and comply with client training requirements.

• 3+ years of previous technical writing experience in a cGMP pharmaceutical environment.
• Experience in manufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements.
• Prior experience working in a biotech/pharmaceutical company.
• Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills.
• Proven ability to communicate complex ideas in a clear, concise manner.
• Working knowledge of MS Office Suite and an Electronic Document Management System (EDMS).
• Experience with Document Proficiency in MS Office Products.

• Associates degree in a scientific discipline or equivalent experience.
• Biological Technical Transfer experience.

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