Technical Document Writer - Biomanufacturing

Description: • 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 of the daily, weekly and monthly forecasted documentation priorities required to meet output quotas. Key responsibilities/essential functions: • 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. Quality Specific Goals: • 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. Required Qualifications: • 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. Preferred Qualifications: • Associates degree in a scientific discipline or equivalent experience. • Cell Culture experience. • Protein Purification experience. • Biological Technical Transfer experience. To know more about this position please contact after applying to the position on; Ujjwal Mane ujwal.mane(at) 973-805-7557 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.