Quality Chemical Laboratories is a contract pharmaceutical testing firm located in Wilmington, NC. We offer a complete benefits package to accepted candidates and is an equal opportunity employer. We are currently seeking candidates in the following positions.
Document Control SupervisorDecember 5, 2017
Document Control Supervisor You will be part of a growing lab support group and part of an agile team to create a strong, collaborative culture. Prefer at least 2 years of previous document control experience, preferably in a regulated industry. Responsibilities: Schedules and oversees the implementation of new document control projects. Authors and reviews documents regarding document control procedures. Maintains training requirements for self and all direct reports. Schedules and manages project work for document control direct reports. Supports QA Director/Manager during client audits. Works with quality group to ensure compliance for all document control duties and project implementation. Maintains adherence to QCL SOPs. Compliance with cGMPs and company policies and procedures. Trains and mentors all direct reports. Communicates daily with direct reports regarding project status and daily workload. Communicates with Document Control Manager to maintain current and implement new processes. Maintains strict client confidentiality. Maintains and troubleshoots problems with company databases. Performs all document control associate duties as needed. Performs other related duties, as required. Requirements: Bachelor’s Degree or its equivalent and 0-2 years of experience in the pharmaceutical field or in a related area. Proficient in Word, Excel, Access and other Microsoft programs. Experience with other GMP compliance systems (e.g. Quality management system, change management systems, ERP) is a plus. Experience in a pharmaceutical company preferred Excellent interpersonal and communication skills required Must be able to solve complex business problems and present recommendations to management effectively Strong verbal and technical writing skills Must be results driven, a quick learner, and a self-starter
Document Control AssociateDecember 5, 2017
Document Control Associate You will be part of a growing lab support group and part of an agile team to create a strong, collaborative culture. Prefer 0-2 years of previous document control experience, preferably in a regulated industry. Responsibilities: · Maintains document and revision information. · Monitors tasks relating to documents. · Reconciles and updates each SOP manual. · Complies with cGMPs and company policies and procedures. · Supports Document Control Supervisor and QA Director/Manager during client audits. · Scans files/records/data as needed. · Files records as needed. · Prepares files for archive storage. · Performs other related duties, as required. Requirements: High school diploma or its equivalent and 0-2 years of experience in the pharmaceutical field or in a related area. Must be proficient in Word, Excel, Access and other Microsoft programs. Experience with other GMP compliance systems (e.g. Quality management system, change management systems, ERP) is a plus. Experience in a pharmaceutical company preferred Excellent interpersonal and communication skills required Must be able to solve complex business problems and present recommendations to management effectively Strong verbal and technical writing skills Must be results driven, a quick learner, and a self-starter
Chemist II/Scientist (HPLC or GC Development and Validation)November 30, 2017
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.
QC ChemistNovember 30, 2017
Seeking highly motivated QC chemists for our growing analytical laboratory. Responsibilities of the positions include routine testing of drug products, active pharmaceutical ingredients and/or excipients 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.
Formulation Development ScientistNovember 30, 2017
Seeking a highly motivated pharmaceutical scientist for our start-up formulation development laboratory. The current focus is solid oral dosage forms but other dosage form experience will be considered as this is a growth area for the company. Must be a self-starter and capable of working independently from concept to product prototype. The successful candidate will preferably possess an advanced degree and a minimum of 3 years of formulation development experience. Familiarity with analytical techniques, regulatory requirements, and cGMP manufacturing is preferred.
LC/MS and GC/MS ScientistsNovember 30, 2017
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.
GMP ReviewersNovember 30, 2017
Seeking highly motivated chemists or microbiologists who have performed QC release or stability 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. 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.
Housekeeping/MaintenanceNovember 30, 2017
Quality Chemical Laboratories has an opening for a part-time or full-time housekeeping/maintenance position in a professional office and laboratory setting. The position includes daily cleaning of multiple offices, bathrooms, break rooms, conference rooms, and laboratories, as well as washing laboratory glassware, mopping, vacuuming, and trash removal. Job duties also include occasional heavy lifting, working on a ladder, standing for long periods, use of common hand tools and floor cleaning/waxing machines. Minimum high school diploma and basic computer and math skills required. Applicants should be mature, hardworking, and dependable with a good work ethic and able to work after regular business hours and on weekends. Qualified candidates should apply through the "Careers" tab via our webiste or email resumes to firstname.lastname@example.org
Metrology/Instrumentation TechnicianNovember 30, 2017
Quality Chemical Laboratories is seeking a full time Metrology/Instrumentation Technician. This individual would work with test and measurement equipment to perform single, multi-discipline electrical, chemical, and process monitoring calibrations of laboratory instrumentation. Job responsibilities also include developing and writing calibration procedures based on component specifications using spreadsheets, flow charts, and word processing software. Individuals would also perform system troubleshooting on all equipment types to the board level, review documentation, checklists, and manuals for accuracy and completeness. QCL offers competitive salaries commensurate with experience and an excellent benefits package, as well as potential for career advancement and leadership in a rapidly growing company.
LabWare LIMS DeveloperNovember 30, 2017
Quality Chemical Laboratories is seeking a full time Labware LIMS Developer. You will be one of the first to join a new, agile team to create a strong, collaborative culture. Prefer at least 3 years of LabWare configuration, interfacing and data migration experience. Responsibilities: As part of a team, configure LabWare LIMS application based on business requirements and scope. Create system interfaces to instruments, Empower CDS & ERP Systems. Create/modify crystal reports based on business needs. Responsible for the migration of LabWare configurations. Create documentation on solutions, technical requirements, components, and APIs developed as leverageable components. Participate in design and code reviews. Interact with cross functional teams to ensure complete delivery of solutions. Collaborate with Business to roll out new functionalities and adhere to the industry standards and change management procedures, enterprise policies, site procedures and work instructions. Training and interaction with company employees is a large part of the job. Requirements: Must have 3+ years of configuration, migration and interfacing experience in LabWare LIMS application. Experience in creating Crystal Reports for business users. Experience in LIMS system interfaces to instruments, Empower CDS & ERP systems Nice to have experience in supporting validated, 21 CFR Part 11 compliant computer systems or a GxP environment. Experience with other GMP compliance systems (e.g. Quality management system, change management systems, ERP) is a plus. Experience in a pharmaceutical company preferred Excellent interpersonal and communication skills required Must be able to solve complex business problems and present recommendations to management effectively Strong verbal and technical writing skills Must be results driven, a quick learner, and a self-starter
System Validation and Data Integrity SpecialistNovember 30, 2017
Quality Chemical Laboratories is seeking a full time System Validation and Data Integrity Specialist. A Bachelor’s degree in an IT or related discipline with 2 to 4 years’ experience or an equivalent combination of education and experience is preferred. Responsibilities: Plans and writes protocols for computer system validation projects per 21 CFR Part 11 Reviews validated systems to assess need for further enhancements, validation, or system upgrades/fixes Works with company management to implement changes and upgrades to computer systems Works with vendors on purchasing and planning for changes and upgrades Ensures 21 CFR Part 11 compliance for all computer systems Initiates computer system change controls Ensures the validated state of all existing computer systems Reviews vendor protocols/design specifications for accuracy and feasibility for new computer systems Performs risk assessments for existing and new computer systems Monitors validation activities and communicates problem areas to quality assurance management Ensures the integrity of all data generated by validated computer systems Participates in client and regulatory audits providing support for inquiries regarding IT practices and procedures, system SOPs and computer system validations Collaborates with other representatives from the quality department to complete internal audits of the IT department and computer systems Coordinates end user training initiatives on new system rollouts Performs other related duties, as required Reports to the Quality Assurance Director. Requirements: A Bachelor’s degree in an IT or related discipline with 2 to 4 years’ experience or an equivalent combination of education and experience is preferred Experience in a pharmaceutical company preferred Excellent interpersonal and communication skills required Strong verbal and technical writing skills Must be results driven, a quick learner, and a self-starter
Quality Specialist - ManufacturingNovember 30, 2017
The Quality Specialist is a vital member of the Quality Team, and key partner with the Manufacturing and Formulations Team. It is the function of the Quality Specialist to effectively perform the necessary and varied activities that ensure quality and compliance with applicable regulatory requirements in pharmaceutical manufacturing. These activities include reviewing documents and data, conducting process-focused audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis. May serve as quality representative for manufacturing/formulation during client audits and provide support during regulatory inspections. Assists with the development of SOPs or other quality documents as needed. Mentor and train other employees in quality and compliance matters. In the support of manufacturing/formulation areas: perform quality release of materials, products, equipment and facilities. Essential Job Requirements: Education · Bachelors degree in Chemistry, Biology, or related field with 5+ years GMP manufacturing related experience is preferred. Knowledge/Skills/Abilities · Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps well informed of new regulations and regulatory guidance in areas of expertise. · A self-starter and the ability to act independently · Good written and oral communication skills. · Good computer skills and knowledge of Microsoft Office products. · Ability to be trained and to mentor. · Ability to interact well with employees at all levels. · Ability to participate in audits. Supervision Received: Limited Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. May determine the methods and procedures on new assignments, but still accomplishes goals within defined procedures and practices. Seeks management direction for problems of diverse and/or complex scope. Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts and a high noise environment. The employee will be required to gain access to lab or manufacturing areas for inspections or work discussions. The employee would need to be able to work with controlled substances. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.