QC Technical Writer Position Available In Middlesex, New Jersey

QC Technical Writer 3.3 3.3 out of 5 stars Cranbury, NJ 08512

Key Responsibilities:

1. Prepare, revise, and finalize technical documents such as analytical method validation protocols/reports, method transfer reports, summaries, 2. Prepare standard operating procedures (SOPs) for analytical instrument operation and lab systems. 3. Prepare risk assessment repots (Residual solvents/Elemental impurities/Nitrosamine) as per USP and ICH/FDA guidelines. 4. Coordinate with QA and project management teams to implement feedback and ensure readiness for audits and submissions. 5. Prepare test methods and raw material and finished product speciation in line with

USP/ICH/FDA

guidelines. Maintain up-to-date copies of all cGMP documents in the laboratory and relevant databases. Assist in preparing documentation for regulatory submissions (FDA and EMA) and audits (internal and external).

Technical Skills:

Strong understanding of analytical techniques (HPLC, GC, UV-Vis, FT-IR, Malvern PSD, Water by KF and Dissolution, etc.) and laboratory procedures. Familiarity with regulatory guidelines such as FDA, ICH, USP, EP, cGMP, and GLP.

Qualifications & Requirements:

Education:

Bachelor’s or master’s degree in Pharmaceutical Sciences, Chemistry, Microbiology, or a related field.

Experience:

7-10 years of experience in technical writing within the pharmaceutical industry, preferably in Quality Control/Analytical Development.

Job Types:

Full-time, Temp-to-hire Pay:

$36.05 – $43.20 per hour Expected hours: 40 per week

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Retirement plan Vision insurance

Schedule:

8 hour shift Monday to

Friday Experience:

Technical writing: 7 years (Required) Ability to

Commute:

Cranbury, NJ 08512 (Required) Ability to

Relocate:

Cranbury, NJ 08512: Relocate before starting work (Required)

Work Location:

In person