Quality Investigator/Technical Writer -2nd shift

ReviveRX & Ways2Well; Houston (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

A health and wellness company located in Houston, TX, is seeking a Quality Investigator/Technical Writer. The role involves conducting investigations related to product quality, performing technical writing for quality documentation, and ensuring compliance with regulatory standards. Ideal candidates will have 3-5 years of experience in Quality Assurance and excellent communication skills. This position offers a chance to contribute to high standards of patient safety and product quality.

Qualifications

• 3–5 years of experience in Quality Assurance or Manufacturing.
• Experience in investigations, writing CAPAs, and batch record review.
• Strong understanding of FDA and USP requirements.

Responsibilities

• Lead and document investigations related to deviations and nonconformances.
• Perform detailed root cause analyses using appropriate quality tools.
• Draft and maintain controlled documents including SOPs and quality summaries.
• Perform comprehensive review of batch records to ensure compliance.
• Support internal audits and contribute to process optimization.

Skills

Technical writing

Analytical skills

Attention to detail

Problem-solving

Communication

Education

Associate’s degree or equivalent work experience

Tools

Qualityze

MasterControl

TrackWise

Microsoft Office Suite

Job description

Job Title: Quality Investigator/Technical Writer - 2nd shift

Department: Quality Assurance

Location: Revive Rx Houston, TX (Onsite)

Shift: Monday-Thursday 8am-5pm OR 12pm-11pm

Reports To: Quality Assurance Manager

Our Quality Investigator ensures the highest standards of product quality and patient safety. After training, you’ll conduct and write incident and deviation investigations, collaborate with Operations and support teams to identify root causes, implement corrective actions, and assess product impact.

What the Quality Investigator Does Each Day:

• Independently author and resolve deviations in order to meet production and product release requirements
• Communicating across multiple groups and levels to drive deviation closure
• Identifying interdepartmental process improvements and working cross-functionally to implement them
• Utilizing advanced root cause analysis techniques and technical impact analyses during the deviation investigation process
• Managing multiple priorities either independently or as part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
• Communicating (both written and verbal) progress and updates across multiple levels of the organization
• Performing more complex deviation investigations
• Participating in the training process and coaching of new team members and processes
• Helping assist with metric reporting and workload to meet the team’s priorities

Key Responsibilities:

1. Quality Investigations:

• Lead and document investigations related to deviations, nonconformances, out-of-specification (OOS), and out-of-trend (OOT) results.
• Perform detailed root cause analyses using appropriate quality tools (e.g., 5 Whys, Fishbone, Fault Tree).
• Develop and implement effective corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams to ensure timely closure of investigations and CAPAs.
• Identify trends and recommend process improvements to reduce recurring quality issues.

2. Technical Writing:

• Draft, revise, and maintain controlled documents including SOPs, batch records, protocols, reports, and quality summaries.
• Ensure all documentation complies with internal standards, cGMP, USP, and regulatory requirements (FDA, USP <797>/<800>, etc.).
• Review and edit technical content for accuracy, clarity, and consistency across all quality systems documentation.
• Support audit preparation by maintaining well‑organized, inspection‑ready documentation.

3. Batch Review and Release:

• Perform comprehensive review of executed batch records, analytical data, and supporting documentation to ensure compliance with specifications.
• Verify that all deviations, changes, and investigations related to the batch are properly documented and closed prior to release.
• Coordinate with QC and Production to ensure timely disposition of materials and finished products.
• Maintain batch release logs and documentation in accordance with data integrity requirements.
• Support release of compounded sterile and non‑sterile preparations, ensuring adherence to cGMP and internal quality standards.

4. Continuous Improvement & Compliance:

• Support internal audits and participate in regulatory inspections as required.
• Identify and implement opportunities for process optimization and documentation efficiency.
• Provide training and guidance to personnel on quality systems, investigation techniques, and documentation best practices.
• Contribute to maintaining a culture of quality and compliance throughout the organization.

Experience:

• 3–5 years of experience in Quality Assurance, Quality Systems, or Manufacturing within a pharmaceutical, biotech, or compounding environment.
• Experience performing investigations, writing CAPAs, and conducting batch record review under cGMP regulations.
• Strong understanding of FDA, USP, and state pharmacy board requirements.
• Associate’s degree or equivalent work experience (preferred)

Skills and Competencies:

• Excellent technical writing and documentation skills.
• Strong analytical and problem‑solving abilities.
• High attention to detail and commitment to data integrity.
• Proficiency with electronic quality systems (e.g., Qualityze, MasterControl, TrackWise) and Microsoft Office Suite.
• Effective communication and collaboration skills across departments.
• Ability to manage multiple priorities and meet deadlines in a fast‑paced environment.