What are the responsibilities and job description for the Technical Writer position at KVK TECH?
Department: Technical Services
Job Title: Technical Writer
FLSA Status: Exempt
ROLE PURPOSE: Primary responsibility is the preparation of technical documents, including Standard Operating Procedures, Manufacturing Batch Records, Protocols, and Reports. Additional responsibilities may include investigating and documenting all deviations and customer related complaints related to the Manufacturing, Packaging and Shipping/Receiving departments by reviewing all related documents, and interviewing relevant personnel so as to identify the root cause and corrective actions required. Also, to change or correct any related documents pertinent to the conclusion of the investigation (i.e., SOP’s) while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.
KEY DUTIES & RESPONSIBILITIES:
- Prepare and review Master production and packaging batch records
- Prepare and review Validation Protocols and reports
- Prepare Quality Event Records (including deviation, incident reports, planned deviation and product complaint investigations)
- Prepare and Review Risk Assessments, CAPAs, Change Control documents and Standard Operating Procedures (SOPs)
- Handles and completes special projects as required
- Other duties as assigned or delegated
TYPICAL SUPERVISORY RESPONSIBILITY:
N/A
EDUCATION & EXPERIENCE:
B.S. or higher degree from an accredited college/university in a scientific discipline or English preferred.
TECHNICAL COMPETENCIES/CERTIFICATIONS/LICENSES:
- Practical working knowledge of Pharmaceutical Manufacturing Operations preferred
- Excellent English writing, spelling, punctuation, and grammar skills
- Ability to interpret complex data and draw valid conclusions
- Proficient in the use of spreadsheets, databases, presentation, and word processing software. Basic Microsoft Office proficiency is expected.
- Strong interpersonal skills and the ability to effectively work and communicate with cross-functional teams
- Strong organizational and multi-tasking abilities
- Self-motivated, work well independently and as a team player and re-prioritize workload as required
- Continuous working knowledge of applicable cGMP guidelines and DEA regulations
Job Type: Full-time
Pay: $55,000.00 - $65,000.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
Work Location: In person
Salary : $55,000 - $65,000
