QUALITY CHEMICAL LABS Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking a highly qualified candidate to manage the extractables and leachables (E/L) laboratory. The candidate must be able to write and execute protocols and generate final reports. Five years of experience in this area is desirable. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our 5-Star childcare facility. For more information about our company and our available positions, please visit our website @ Qualified candidates may also apply via our website, or email resumes to Quality Chemical Laboratories (QCL) serves the biopharmaceutical industry. We provide expert and cGMP compliant scientific testing services in support of both small and large-molecule drug products, drug substances, in-process materials, and raw materials in all phases of Research, Development, and Commercialization. QCL provides formulation development and solid dose GMP manufacturing supporting early-phase clinical trials. QCL is adding sterile fill/finish and lyophilization services launching in 2024.
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study tables and will be expected to review reports for completeness and accuracy to ensure compliance with GMPs and SOPs. This position requires outstanding attention to detail, documentation, communication, problem-solving and organization skills. With experience, the candidate may be required to review technical reports such as method verifications, validations, transfer activities and other protocol driven work. Candidate must be proficient in Word and formatting documents. Additional quality assurance responsibilities may be required. QCL offers competitive salaries commensurate with experience and an excellent benefits package as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. QCL is an equal opportunity employer.
GMP Data Reviewers, Chemists, Metrology, LabWare, CPU Validation, Stability, Sample Log-In, and Document Control Positions Quality Chemical Laboratories (QCL), a pharmaceutical testing and development lab in Wilmington, is seeking highly motivated candidates for qualified analytical data reviewers, LabWare LIMS development/configuration/validation, Document Control Associates, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Pharmaceutical Formulation (with knowledge of manufacturing equipment), Metrology, and Sample Log-In Associates. Special attention is given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration will also be given to experienced GMP data reviewers. Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. QCL is an equal opportunity employer.
Quality Chemical Laboratories (QCL), a pharmaceutical testing, manufacturing, and development lab in Wilmington, is seeking a highly motivated scientist for our formulation development laboratory. The focus of this position is solid oral dosage forms but other dosage form experience, especially parenterals, will be considered as this is an area of growth for the company. Must be capable of working independently from concept and product prototype through transfer to cGMP Manufacturing. The ideal candidate will possess strong problem-solving abilities, excellent customer service mindset, and a positive can do attitude. A college degree is required with at least 3 years experience in formulation development. Experience in process development and technology transfer into cGMP manufacturing, familiarity with analytical techniques, regulatory requirements, and early phase cGMP manufacturing is preferred. Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. QCL is an equal opportunity employer.
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of licensed HVAC Technician. This position requires a minimum of an associate's degree from a two-year college or technical school with a certificate or military training and experience in Heating, Ventilation, and Air Conditioning and 10+ years of HVAC experience is preferred. The candidate will be responsible for the installation, maintenance and repair of HVAC systems utilizing knowledge of refrigeration theory, electrical schematics, pneumatic and building automation systems (BAS), pipe fitting, welding and brazing and mechanical layouts. Other duties include following blueprints/specifications to diagnose and repair units, documentation, ability to work outdoors and/or in mechanical rooms, and flexibility to work weekends if necessary. Candidate must be proficient with laptops, tablets, smart phones, Microsoft Office, Adobe and basic apps. Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. For more information about our company and our available positions, please visit our website @ . Qualified candidates should email resumes by clicking APPLY NOW to submit your resume today! QCL is an equal opportunity employer.
QUALITY CHEMICAL LABS Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking an experienced and dedicated Utilities Engineer to join our team. This person will be responsible and accountable for overseeing the qualification, validation, maintenance and repair of our utilities and HVAC systems, ensuring that all are compliant with applicable regulations for GMP pharmaceutical operations and meet safety standards. The Utilities engineer role is to ensure that the organization s clean utilities that support GMP manufacturing operations in both sterile and non-sterile sites remain in a validated state of control with minimum downtown and operate efficiently and safely. The ideal candidate is a strategic planner with an excellent project management mindset, experienced with GMP documentation, comfortable in a fast-paced environment managing a multitude of contractors, and preferably specialized in working in sterile fill/finish pharmaceutical facilities. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our 5-Star childcare facility. For more information about our company and our available positions, please visit our website @ Qualified candidates may also apply via our website, or email resumes to
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor s degree or higher in a scientific or engineering discipline with either 3 years of experience or an equivalent combination of education and experience in a GMP laboratory or GMP manufacturing environment. Responsibilities include performing GMP review of manufacturing records and data, review and release manufacturing product batches, review and approve deviations, SOPs, calibration records, and protocols, perform AQLs as required, and assist with client audits. Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. QCL is an equal opportunity employer.
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Validation Engineer. This position, in the Manufacturing and Formulations Services department, requires a Bachelor s degree or higher in a scientific or engineering discipline with either 3 years of experience or an equivalent combination of education and experience in a GMP laboratory or manufacturing environment. Special consideration given to candidates with experience with automated filling equipment especially in a sterile manufacturing environment. Responsibilities include: create and execute equipment installation and operational qualification/requalification, calibration, and preventative maintenance for manufacturing instruments and equipment, as well as facilities and utilities qualifications /develop Standard Operating Procedures and training materials for manufacturing equipment / perform Factory Acceptance Tests for new equipment at vendor sites/monitor ViewLinc and respond to excursions as needed/perform data trending and write reports, change requests, and deviations / communicate with clients, manufacturing and formulations management, and the quality group. Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control, Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. QCL is an equal opportunity employer.
Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Computer System Validation Specialist. Responsibilities: Performs and leads computer system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle. Documentation includes Computer System Validation Plan, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment. Track and resolve deviations/exceptions during qualification activities. Work with company management to implement changes and upgrades to computer systems Work with vendors on purchasing and planning for new lab equipment/software upgrades, review vendor protocols/design specifications Communicate Computer System Validation approaches and requirements during audits. Review validated systems to assess need for further enhancements, validation, or system upgrades/fixes Qualifications: Two (2) years of experience with Computer System Validation in GxP environment (preferably pharmaceutical industry). Experience in writing computer system test scripts, validation protocols and summary reports
Knowledge of Regulatory Requirements, 21CFR11, Data Integrity Guidance, GAMP and industry best practices for validation to complete tasks Proficient in analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution Capable of managing multiple sub-projects, duties and tasks Effective at communicating clearly and concisely, both orally and in writing Able to work both independently and as a member of a cross-functional project team Quality Chemical Laboratories (QCL) is a rapidly growing pharmaceutical testing and manufacturing lab in Wilmington, NC. We are seeking highly motivated candidates for multiple positions throughout the company in the areas of analytical data review, LabWare LIMS development/configuration/validation, Document Control , Computer System Validation and Data Integrity Specialists, Scientists (all levels) with experience in Mass Spec, LC, GC, QC compendial testing, Wet Chemistry, Microbiology, Sterility, Synthetic Chemistry, Biotech, Pharmaceutical Formulation and Manufacturing (requires knowledge of manufacturing equipment), Validation Engineers, Metrology, Report Generation, Sample Log-In Associates, and HVAC Technicians. Special attention given to candidates with an advanced degree in Chemistry or related science and experience in method development/validation. Special consideration also given to experienced GMP data reviewers. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as great potential for career advancement and leadership in a rapidly growing company. We now also offer subsidized childcare at our newly acquired childcare facility. QCL is an equal opportunity employer.
