QA Investigations / Technical Writer

Responsibilities

• Investigate and document quality events including deviations, incidents, planned deviations, OOS investigations, and customer complaints.
• Perform and document root cause analyses and develop appropriate corrective and preventive actions (CAPAs) in alignment with regulatory expectations.
• Draft, revise, and maintain controlled documentation such as SOPs, batch records, qualification and validation protocols, technical reports, and risk assessments.
• Support change control activities related to manufacturing processes, equipment, facilities, and quality systems.
• Collaborate with Manufacturing, Packaging, Engineering, and Quality teams to ensure documentation accuracy and procedural alignment.
• Support continuous improvement initiatives through trend analysis, audit observations, and quality system enhancements.

Requirements

• Bachelor’s degree in a scientific or technical discipline such as Chemistry, Biology, Pharmacy, or Engineering required; Master’s degree preferred.
• Minimum 3–5+ years of experience in a pharmaceutical or regulated manufacturing environment.
• Demonstrated experience in technical writing, deviation and CAPA management, and change control systems.
• Working knowledge of cGMP requirements (21 CFR Parts 210/211) and FDA quality system expectations.
• Strong written communication, analytical, and organizational skills with a high attention to detail.

Qualifications

• Must have a valid driver’s license and reliable transportation.
• Ability to work flexible hours as needed.

Skills

• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Experience with quality management systems (e.g., SAP, Oracle).
• Knowledge of GMP regulations and Good Manufacturing Practices.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays