Target Hiring Date
January 2025
Salary
$40-50 Per Hour
Work Authorization
Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.
Requirements
Education and Experience:
BA/BS degree required, with a preference for degrees in science or engineering.
1-3 years of experience in technical writing, with 3+ years in the pharmaceutical industry preferred.
Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
About the Role
As a Technical Writing Specialist at Sokol GxP Services, you will play a key role in supporting the implementation of laboratory equipment and systems at our multi-use sites. You’ll work closely with both internal teams and external service providers to contribute to milestone achievements related to facility, utility, and equipment qualification. With general supervision, you’ll independently perform routine tasks and utilize your analytical skills to solve common problems. This role is perfect for someone eager to grow, collaborate, and build lasting relationships across the organization.
Supervisory Responsibilities: None.
DUTIES / RESPONSIBILITIES
________ Knowledge, Skills & Abilities ________
- Exceptional technical writing skills, including proficiency in Microsoft Word formatting, ensuring the creation of technically accurate documents in line with validation programs.
- Process-oriented with strong critical thinking and problem-solving abilities.
- In-depth understanding of cGXP requirements and good documentation practices within the pharmaceutical industry.
- Experience in creating Standard Operating Procedures, Work Instructions, Risk Assessments, and authoring/validating commissioning/qualification/validation deliverables.
- Ability to handle protocol deviations, conduct investigations, and implement corrective/preventive actions.
Strong organizational skills to manage multiple tasks in a fast-paced environment.
- Excellent written and verbal communication skills, with the ability to present information clearly and interact effectively with cross-functional teams.
- Advanced proficiency in Microsoft Office Suite; experience with Blue Mountain Regulatory Asset Manager and Veeva Vault is a plus.
________ Key Responsibilities ________
- Develop and execute commissioning, qualification, and validation documents for manufacturing equipment, utilities, and facilities.
- Handle protocol deviations, investigations, corrective actions, and change controls as needed.
- Write detailed procedures for the operation, cleaning, and maintenance of equipment.
- Ensure all documents comply with company standards and policies.
- Provide excellent customer service and foster positive relationships with team members and site customers.
About the Company
Join Sokol GxP Services – Where Innovation Meets Integrity!
Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation, offering competitive health benefits, PTO, holiday pay, volunteer hours, a relocation budget*, a 401K** program, and professional development opportunities. Plus, take advantage of our Employee Referral program! Be part of a dynamic team with fantastic opportunities for growth and professional development!
Let’s shape the future of life sciences together!
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All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.
Equal Opportunity Employer Statement:
Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
*Relocation support will be determined on a case-by-case basis.
**Our 401K program is set to launch in the 2025 fiscal year.
By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.