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.
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.
QualificationsRequired 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.
Additional InformationTo know more about this position please contact after applying to the position on;
Ujjwal Mane
ujwal.mane(at)collabera.com
973-805-7557
Skills Required
- 3+ years of previous technical writing experience in a cGMP pharmaceutical environment
- Experience in manufacturing under cGMP guidelines
- Prior experience working in a biotech/pharmaceutical company
- Exceptional written/verbal communication skills
- Working knowledge of MS Office Suite and Electronic Document Management System
Collabera Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Collabera and has not been reviewed or approved by Collabera.
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Fair & Transparent Compensation — Pay is considered acceptable to strong on select technical contracts and in certain geographies, with some assignments described as substantially above typical consultant rates. Outcomes appear closely aligned to client budgets and market conditions, delivering solid value in higher‑demand niches.
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Career-Linked Recognition & Rewards — Compensation tends to track niche skills and client demand, leading to more favorable pay for specialized technical roles and markets. This structure helps some cohorts perceive their pay as market‑competitive.
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Wellbeing & Lifestyle Benefits — Offerings include access to mental‑health therapy sessions and gym membership or reimbursement. These additions complement core coverage in some roles.
Collabera Insights
What We Do
In our relentless pursuit of greatness, we are dedicated to developing individuals, creating exceptional teams, and cultivating a unique culture of unity and care. As providers of digital talent solutions, we aim to positively impact businesses and communities globally. We would be honored to be your trusted and uncommon partner on this journey.
