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Job DescriptionDescription: Quality Control Investigation Writer 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. Key Competencies Technical Writing Laboratory Investigation Expertise Root Cause Analysis GMP Compliance FDA Regulatory Knowledge Quality Systems Analytical Problem Solving Cross-Functional Collaboration Risk Assessment Continuous Improvement

Job Description What You’ll Do (Essential Duties and Responsibilities): Lead the completion of accounting activities within one or more of the following accounting discipline areas: AR & AP, Cost Accounting, Financial Reporting, Global Financial Reporting, Internal Auditing, Inventory Control, and Payroll. Ensure that all final work product is timely and GAAP compliant. Ensure that all necessary reports and filings comply with Sarbanes Oxley and SEC regulations. Use GAAP to prepare and manage the timely completion of all relevant reports and disclosures required by the SEC and management. These reports include SEC compliance filings and documents for internal and external reporting. Assist management in making informed decisions by reviewing, analyzing, and explaining financial reports. Take a lead role in coordinating with the necessary internal departments to complete accounting objectives and other company goals. Assist in leading the close reporting process ensuring that all deadlines are met. Perform other duties as assigned. Salary Range: $84,575-$114,425 What You’ll Need (Qualifications): Bachelor’s degree in accounting. 3 years of related experience or training. CPA license is preferred. Strong working knowledge of Microsoft Office. ERP systems experience required; Microsoft Dynamics AX2012 preferred.

Job Description Aptask Global Workforce (AGW) is seeking a Quality Control Investigation Writer for a position with a Global Biotechnology Company located in High Point, NC. This is a 12 month contract opportunity. 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. Responsibilities: • Lead and author Quality Control laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), Environmental Monitoring (EM) excursions, and laboratory deviations, • Collect, review, and analyze laboratory data, test methods, and supporting documentation to determine probable root cause and product impact, • Facilitate investigation meetings with laboratory personnel and cross-functional stakeholders, • Perform and document root cause analyses using established investigation tools and methodologies, • Prepare clear, concise, and comprehensive investigation reports that meet internal procedures and FDA expectations, • Develop scientifically justified impact assessments to determine potential effects on product quality and patient safety, • Author and support associated quality records including Deviations, Corrective and Preventive Actions (CAPAs), and Change Controls, • Review investigation records for completeness, technical accuracy, and regulatory compliance, • Support Quality Assurance during investigation reviews and approvals, • Participate in regulatory inspections and internal audits Requirements: • Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline, • 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, • Demonstrated experience writing OOS, OOT, Environmental Monitoring (EM) investigations, laboratory deviations, CAPAs, and 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, • 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 Desired skills: • 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 Pay range: up to $36.00 per hour Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: • Medical, • Dental, • Vision, • Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

Job DescriptionTitle: 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: At LanceSoft, full-time regular employees who work a minimum of 30 hours a week or more are entitled to the following 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.

Job DescriptionPay Rate Range: $20.00 - $36.00/hr. on W2Summary: • 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.Key Competencies:, • Technical Writing, • Laboratory Investigation Expertise, • Root Cause Analysis, • GMP Compliance, • FDA Regulatory Knowledge, • Quality Systems, • Analytical Problem Solving, • Cross-Functional Collaboration, • Risk Assessment, • Continuous Improvement

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