Technical Writer (Formulation & Production)

Job Description

Department: Quality Assurance

Job Title: Technical Writer

FLSA Status: Exempt

1. 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.

2. 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

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

B.S. or higher degree from an accredited college/university in a scientific discipline or English preferred

5. 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

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to handle or use tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A

Full-time