Seeking highly motivated analysts for our new Raw Material/Wet Chemistry  laboratory. Responsibilities of the positions include routine testing of drug products, active pharmaceutical ingredients and/or experience in a cGMP laboratory. Previous experience with specific techniques is not a job requirement, but the willingness to learn and apply various wet, chromatographic, and spectroscopic techniques is essential. Candidates must be detail oriented, possess strong time management skills, and have demonstrated scientific abilities. A minimum of 1 year of experience working in a cGMP analytical laboratory is preferred. Minimum of Bachelor’s degree in Chemistry or related scientific field is required.

Associate Formulations Scientist

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing
laboratory in Wilmington, is seeking a qualified candidate for the position
of Associate Formulations Scientist

Minimum Requirements: 

This position requires a BS degree or higher in a scientific discipline with at least 5 years of experience or an equivalent combination of education and experience. 

Responsibilities:

 Performs laboratory work including the development and manufacture of pharmaceutical
dosage forms.
Documents laboratory testing with strict adherence to QCL SOP’s and regulatory
standards.
Assists in authoring technical documents such as protocols and reports.
Maintains training requirements on all necessary disciplines.
Assist Metrology group as needed to assist with calibrations, preventative maintenance
and instrument/equipment troubleshooting.
Assists in investigations to determine root causes of events.
Assists in procuring samples and equipment for new development projects.
Can interpret data and analyze results using statistical techniques and software.
Assists warehouse and validation personnel in maintaining equipment/instruments and raw material inventory, especially related to new items needed for development purposes.
Maintains strict client confidentiality.
Participates in client calls, as needed.
Communicates daily with laboratory manager about work scheduling.
Organizes data for analysis and reporting.
Maintains a clean and orderly work environment.
Maintains adherence to safety standards as required by QCL SOP’s.
Performs other related duties, as required.
Reports to the department Manager or Director, as applicable.

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. 

Chemist II/Scientist (HPLC or GC Development and Validation)

Seeking highly motivated scientists to perform HPLC or GC method development and validation.  Must be able to work in a cGMP environment.  Must be able to write development plans, validation protocols, and technical reports ready for regulatory scrutiny.  Will be responsible for project management and direct communication with client contacts.  Requires outstanding writing, documentation, and organizational skills.  A minimum 3 years HPLC or GC development and validation experience preferred.  Experience with FDA, USP, and ICH guidelines is expected.  Minimum of B.S. degree in Chemistry or other closely related field is required. 

Computer System Validation Specialist

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

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. 

Maintenance/HVAC Technician

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.

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.

LC/MS and GC/MS Scientists

Seeking strong, highly motivated LC/MS and GC/MS scientists.  Applicants must be able to perform routine testing on pharmaceutical samples and preferably be able to develop/validate analytical methods as necessary.  Experience working in a cGMP environment together with familiarity with ICH, FDA, and USP guidelines is preferred.  Minimum of 3 years of experience in Mass Spectroscopy, Chromatography, and BS in Chemistry or related field is required.

Manufacturing and Formulations Associate

Quality Chemical
Laboratories (QCL), a leading Pharmaceutical testing and manufacturing
laboratory in Wilmington, is seeking a qualified candidate for the position
of Manufacturing and Formulations Associate. 

Minimum Requirements: 

This position requires an Associate’s degree or higher in a scientific or engineering discipline with 0 to 3 years of experience or an equivalent combination of education and experience.

Responsibilities:

Assist in carrying out any GMP or R&D manufacturing operations.
Assist in the management and handling of all GMP and R&D materials including
receiving material, performing required sampling, and maintaining records to ensure the
timely retesting of materials.
Assist in all cleaning activities.
Perform evaluations including but not limited to Powder Characterizations (Density,
Particle Size, Flodex).
Perform evaluations including but not limited to Tablet Characterizations (weight,
thickness, hardness, friability).
Assist in equipment installations and qualifications as needed.
Perform viable and non-viable monitoring in the GMP Synthesis Clean Room and the
Formulations GMP areas.
Maintain strict client confidentiality.
Work with quality group to ensure compliance for all GMP work.
Communicate daily with manufacturing and formulation management about work
scheduling and project progress/results.
Maintain training requirements on all necessary disciplines.
Maintain adherence to safety standards as required by QCL SOP’s.
Perform other related duties, as required.
Report to the department Manager or Director, as applicable.

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. 

Microbiologists (All Levels)

Quality Chemical Laboratories (QCL), a pharmaceutical testing and development lab in Wilmington, is seeking qualified microbiologists. The ideal candidates should have experience and knowledge of USP testing and be able to perform routine testing such as MLT, bioburden, microbial attributes testing, sterility testing, microbial identifications, and endotoxin testing. Must have knowledge of GMPs and pharmaceutical industry requirements, as well as organizational and managements skills. 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. 

GMP Reviewers/QA Associate

Quality Chemical Laboratories is seeking highly motivated Quality Assurance professionals who have performed data review of analytical and/or microbiological testing in a GMP environment. Responsibilities will include reviewing laboratory projects for compliance with GMPs, SOPs, protocols, technical execution, accuracy of calculations, and completeness of write-up. Additional responsibilities may include laboratory audits, technical summary report review, and internal auditing. Requires outstanding attention to detail, documentation, communication, problem-solving, and organization skills. Minimum 3 years of experience in a GMP environment and preferably bench-level HPLC, GC, wet chemistry, or microbiology laboratory experience. Knowledge of USP, EP, JP compendia and ICH guidance is required.

Technical Services Associate

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing
laboratory in Wilmington, is seeking a qualified candidate for the position
of Technical Services Associate.  

Minimum Requirements: 

This position requires an Associate degree or higher in a scientific or engineering disciplines with at least 3 years of experience or an equivalent combination of education and experience. 

Responsibilities:

Initiate new or revise existing batch records for products and processes.
▪ Create documents for and execute cleanability studies.
▪ Create and maintain cleaning documentation for products and processes.
▪ Create documents for and work with manufacturing and formulations team to execute design
of experiment studies.
▪ Create technical transfer documentation for products and processes.
▪ Develop Standard Operating Procedures and training materials for manufacturing processes,
as applicable.
▪ Create documents for and execute process and product validations.
▪ Perform batch data trending and write reports, change requests, and deviations (as required).
▪ Assist in the production and packaging of R&D and GMP products, as required
▪ Work with the manufacturing, validations and metrology teams to maintain equipment,
utilities and facility in a ready state of compliance including keeping them clean, calibrated
and qualified.
▪ Monitor viewLinc (environmental monitoring system) and respond to excursions as needed.
▪ Work with clients to transfer in/out products and processes.
▪ Assist in the performance and trending of environmental monitoring of the GMP Synthesis,
Manufacturing and Formulation Services areas.
▪ Maintain strict client confidentiality.
▪ Work with manufacturing and formulation management to investigate aberrant data.
▪ Work with quality group to ensure compliance for all GMP work.
▪ Work with Business Development and management to develop timelines for work activities.
▪ Communicate daily with manufacturing and formulation management about work scheduling
and project progress/results.

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. 

Warehouse Associate

Quality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing
laboratory in Wilmington, is seeking a qualified candidate for the position
of Warehouse Associate.  

Minimum Requirements: 

This position requires a minimum of 3 years of experience in a GMP environment or an equivalent combination of education and experience.

Responsibilities:

▪ Provides assistance for all phases of the shipping, receiving and storage of raw materials
and finished goods.
▪ Performs warehouse activities including managing accurate and reliable inventory, and
performing duties of Power of Attorney for scheduled drug items.
▪ Receives incoming items (raw materials, consumables, equipment, etc) and ships finished
goods, as required.
▪ Maintains work areas in a neat and clean condition.
▪ Keeps training up to date and in a state of compliance, as applicable and as required by
QCL SOP’s.
▪ Documents work in adherence to QCL SOPs and regulatory standards.
▪ Participates in client calls, as needed, and provides status updates.
▪ Works with project management, QA and laboratory groups to ensure that materials are
received/released/tested/shipped/disposed of, as appropriate.
▪ Maintains adherence to safety standards as required by QCL SOP’s.
▪ Performs other related duties, as required.
▪ Reports to the department Manager or Director, as applicable.

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.