Business Professional - Technical Writer

Lancesoft; High Point (NC); On-site; USD 28,000 - 50,000; Full time

Benefits offered by this job

Medical Insurance

Dental and Vision Insurance

401k Contributions

Critical Illness Insurance

Voluntary Permanent Life Insurance

Accident Insurance

Other Employee Perks

Job summary

LanceSoft is seeking a Quality Control Investigation Writer to lead and author investigations in a GMP-regulated pharmaceutical environment in High Point, NC. You will work with QC analysts, QA, Microbiology, Manufacturing, and cross-functional teams to ensure scientifically sound conclusions and compliant documentation.

The ideal candidate holds a Bachelor's in a scientific field and has 2+ years of GMP experience with strong technical writing, data analysis, and regulatory knowledge.

Qualifications

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.
• Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment.
• Minimum 1 year of direct experience authoring and leading laboratory investigations within a Quality Control department (preferred).
• Strong working knowledge of FDA regulations, cGMP requirements, and industry guidance related to laboratory investigations.

Responsibilities

• Lead and author Quality Control laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM) excursions, laboratory deviations, and other atypical events.
• Collect, review, and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, and supporting documentation to determine root cause and product impact.
• Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts and develop conclusions.
• Perform and document root cause analyses using established investigation tools and methodologies.
• Prepare investigation reports meeting internal procedures and regulatory expectations (FDA, GMP).
• Develop impact assessments on product quality, patient safety, regulatory compliance, and laboratory operations.
• Author and support Deviations, CAPAs, Change Controls; ensure corrective actions and effectiveness checks.

Skills

Technical writing

Root cause analysis

GMP documentation

FDA regulations knowledge

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline

Tools

TrackWise

Job description

Title: Quality Control Investigation Writer

Location: High Point, NC, 27265

Duration: 0–12+ Months

Pay Rate: $20.00 - $36.00/Hour on W2

Schedule: 1st shift

Position Summary

The Quality Control (QC) Investigation Writer is responsible for leading, authoring, and coordinating laboratory investigations within the Quality Control department in support of GMP-regulated pharmaceutical manufacturing operations. This role serves as a subject matter expert in the investigation process and is responsible for ensuring laboratory investigations are scientifically sound, thoroughly documented, compliant with regulatory requirements, and completed within established timelines. The QC Investigation Writer partners closely with QC analysts, laboratory management, Quality Assurance, Microbiology, Manufacturing, and other cross-functional teams to investigate atypical laboratory events, identify root causes, assess product impact, and develop effective corrective and preventive actions. The position requires extensive experience with laboratory investigations including Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM), and laboratory deviation investigations in an FDA-regulated GMP environment.

Essential Duties and Responsibilities

Lead and author Quality Control laboratory investigations related to:

• Out-of-Specification (OOS) results
• Out-of-Trend (OOT) results
• Environmental Monitoring (EM) excursions
• Laboratory deviations
• Atypical laboratory events
• Invalid assay and microbiological test results
• Data integrity and documentation discrepancies

Collect, review, and analyze laboratory data, test methods, chromatograms, worksheets, instrument records, environmental monitoring data, and supporting documentation to determine probable root cause and product impact.

Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders to gather facts, evaluate evidence, and develop scientifically justified conclusions.

Perform and document root cause analyses using established investigation tools and methodologies.

Prepare clear, concise, and comprehensive investigation reports that meet internal procedures, FDA expectations, and current GMP requirements.

Develop scientifically justified impact assessments to determine potential effects on product quality, patient safety, regulatory compliance, and laboratory operations.

Author and support associated quality records including:

• Deviations
• Corrective and Preventive Actions (CAPAs)
• Change Controls

Ensure investigations include appropriate corrective actions, preventive actions, effectiveness measures, and follow-up activities where required.

Review investigation records for completeness, technical accuracy, regulatory compliance, and adherence to established timelines.

Support Quality Assurance during investigation reviews and approvals.

Participate in regulatory inspections, internal audits, and customer audits by providing investigation documentation and supporting responses to investigator inquiries.

Identify recurring laboratory issues and recommend process improvements to reduce repeat events and improve laboratory compliance.

Qualifications

Education

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline required.

Required Experience

Minimum 2 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics environment.

Minimum 1 years of direct experience authoring and leading laboratory investigations within a Quality Control department (preferred).

Demonstrated experience writing: OOS investigations OOT investigations Environmental Monitoring (EM) investigations Laboratory deviations CAPAs Change Controls.

Strong working knowledge of FDA regulations, cGMP requirements, and industry guidance related to laboratory investigations.

Experience conducting scientific evaluations and root cause analyses for laboratory events.

Experience reviewing analytical chemistry and/or microbiological testing data.

Preferred Experience

Experience using electronic Quality Management Systems such as TrackWise.

Familiarity with FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and Current Good Manufacturing Practice regulations.

Knowledge, Skills, and Abilities

Advanced technical writing and documentation skills.

Strong understanding of laboratory operations, analytical testing, microbiological testing, and GMP documentation practices.

Ability to critically evaluate complex laboratory data and identify scientifically defensible conclusions.

Strong knowledge of investigation methodologies, root cause analysis tools, and quality risk management principles.

Ability to communicate effectively with laboratory personnel, Quality Assurance, Manufacturing, and senior leadership.

Excellent organizational skills with the ability to manage multiple investigations simultaneously.

Strong attention to detail and commitment to data integrity and regulatory compliance.

Employee Benefits

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal-opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.