Technical Writer (Springfield, NJ)
- Technical Documentation: Author, edit, and maintain a wide range of documents, including Standard Operating Procedures (SOPs), batch records, validation protocols, technical reports, change control documents, and regulatory submissions in accordance with GMP guidelines.
- Compliance: Ensure all written materials meet regulatory and GMP requirements, and align with the company’s quality standards, procedures, and policies.
- Collaboration: Work closely with both Client stakeholders and client stakeholders to establish alignment on deliverables and ensure project timelines are maintained.
- Document Management: Assist in the management of controlled documents in document control systems (e.g., electronic document management systems), ensuring traceability, version control, and appropriate distribution of approved documents.
- Process Improvement: Participate in process improvement initiatives related to document control, writing standards, and compliance, ensuring continuous enhancement of documentation practices.
- Audits & Inspections: Support internal and external audits by preparing relevant documentation and ensuring that all technical writing adheres to current regulatory standards.
- Change Control: Document and track changes in manufacturing processes, equipment, and methodologies, ensuring updates to procedures and records are properly reflected.
- Education: Bachelor's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Engineering, or a related field. Advanced degree or certification in technical writing is a plus.
- Experience:
- Minimum of 2 years of experience in technical writing within a GMP-regulated environment in the pharmaceutical, biotech, or related industry.
- Experience writing technical documentation, including SOPs, validation protocols, and reports.
- Knowledge:
- Solid understanding of GMP regulations (FDA, EMA, ISO, ICH, etc.) and regulatory requirements for pharmaceutical manufacturing.
- Proficiency with document management systems and Microsoft Office Suite (Word, Excel, PowerPoint).
- Skills:
- Exceptional written and verbal communication skills, with a strong ability to translate complex technical concepts into clear, concise documentation.
- Detail-oriented with strong organizational and project management skills.
- Ability to work independently, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment.
- Strong analytical and problem-solving skills, with the ability to work cross-functionally across departments.
Recommended Jobs
Automotive Sales Associate
Job Description Job Description Location : Asbury Park, NJ ACURA OF OCEAN IS NOW HIRING AUTO SALES REPS Acura of Ocean will provide you a family friendly environment, that is customer focu…
Registered Nurse (RN) - Endoscopy
Job Title: RN Location: RWJUH Somerset Department Name: Endoscopy Room Req #: 0000246401 Status: Hourly Shift: Day Pay Range: $46.90 - $63.44 per hour Pay Transparency: The abo…
Child and Adolescent Psychiatrist - 1659
Child and Adolescent Psychiatrist – 1659 Child Psychiatrist – 100% OP – Princeton *100% Outpatient Work for a Child Psychiatrist *Work in a very successful private practice earning $250K- $350…
Labor & Delivery Registered Nurse (RN)
JOB SUMMARY The LABOR & DELIVERY REGISTERED NURSE (RN) is a healthcare provider who through education and experience possesses a distinct body of knowledge and skills relative to the care of the adol…
Adjunct Opportunities - Health Professions
Job Description Job Description Please join us on Tuesday, June 2nd at 4pm for our annual Adjunct Job Fair - located on our Paramus Campus in the Technology Building (TEC-128). The Adjunct Job Fa…
Medical Scribe, Emergency and Hospitalist Medicine
Job Title: Medical Scribe Location: Emergency Medicine Associates Department: ER Physician-Medical Group Req#: 48615 Status: Per Diem Shift: Day Pay Range: $17.67 - $17.67, per hour …
Anesthesiologist Full-time
Job Description Job Description Physicians’ Practice Enhancement, LLC is committed to the highest level of patient, hospital and physician satisfaction. As a physician-led organization, we recogn…
Customer Experience Specialist
What To Expect At Tesla, our Customer Experience Specialists are at the heart of everything we do. They deliver exciting, engaging, and educational experiences that leave a lasting impression on b…
Office Support Professional
Requisition Number: 224033 Job Description Cintas is seeking an Office Support Professional to support numerous office functions. Responsibilities include accounts receivable, accounts payable…