Quality Control Laboratory Job Description

Quality Control Laboratory Job Description

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Quality control laboratory provides training, instruction and adherence to analytical testing, safety procedures, ISO-9001:2015 and other external standards and current good manufacturing practices(cGMP).

Quality Control Laboratory Duties & Responsibilities

To write an effective quality control laboratory job description, begin by listing detailed duties, responsibilities and expectations. We have included quality control laboratory job description templates that you can modify and use.

Sample responsibilities for this position include:

Under general supervision, lead the personnel and functions of the Analytical Chemistry Laboratory, Microbiology Laboratory, QC Receiving Inspection, and Stability Program, assuring that department, site and Company goals are met
Understands and is proficient in methods (Quality manual, CDC’s, ) and trains and ensures proficiency among staff
Shall work with Chief, NCD, Study Directors, principal investigators, and other key staff to perform QC reviews of documents and records associated with nonclinical studies, to include those conducted under FDA Good Laboratory Practice (GLP) requirements
Shall perform QC review of laboratory study files and records to assure that calculations, content, reference, are technically correct and complete for submission for QA audit
Shall perform QC review of GLP study final reports and other high visibility final reports to assure that calculations, content, reference, are technically correct and complete for submission for QA audit
Shall coordinate and manage troubleshooting, unexpected incident investigations, and corrective action/ preventive action (CAPA) activities related to NCD-supported studies and facilities
Shall represent Nonclinical Development Division in study and project team meetings, coordinating activities with Study Directors and study personnel
Shall coordinate with QAU staff on scheduling and quality standards for submissions for QA audit coordinating the scheduling and tracking for all quality control activities within NCD
Shall ensure compliance with FDA regulations, , 21CFR314, where the goal is inclusion in FDA animal rule submission in review of records and documents
Shall apply scientific knowledge and regulatory expertise in executing assignments and assisting other supported teams

Quality Control Laboratory Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Control Laboratory

List any licenses or certifications required by the position: ASCP, SAP, ASQ, 9001, ISO, ISO9000, IATF

Education for Quality Control Laboratory

Typically a job would require a certain level of education.

Employers hiring for the quality control laboratory job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Chemistry, Science, Biology, Technical, Microbiology, Engineering, Biochemistry, Associates, Education, Life Science

Skills for Quality Control Laboratory

Desired skills for quality control laboratory include:

SAP
Laboratory analytical testing procedures and specific lab equipment to perform quality testing
Titrating
Analytical chemistry
ISO 9001 and Statistical Process Control Techniques
ISO9001:2015 Quality Management System
Preparing volumetric solutions
Ability to interact with diverse customers
Another language besides English is an asset
Blood products

Desired experience for quality control laboratory includes:

Shall remain abreast of current FDA regulatory requirements, guidance, and current thinking to enhance the expertise and awareness of NCD staff
Shall provide advice on, review and revise Standard Operating Procedures (SOPs), testing plans, and protocols related to laboratory testing analytical methodology and general laboratory activities
Based on USAMRIID’s current mission it will be necessary to provide surge data quality control support in different areas throughout the period of performance of the task order
This position has the option to telework based on the recommendation and approval of the Technical Point of Contact and the Contracting Officer's Representative
Support the analytical, microbiological, and QC inspection needs of the facility by effective use of resources
Ensure the desired quality of product has been achieved and maintained by operations personnel through the application of established quality standards to raw materials, in process materials, bulk product, finished goods, complaint, stability samples, and testing to support cleaning validation

Quality Control Laboratory Examples

1

Quality Control Laboratory Job Description

Job Description Example
Our company is searching for experienced candidates for the position of quality control laboratory. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality control laboratory
  • Oversee group that may develop, transfer, and validate new analytical and microbiology methods and complete testing on complaint samples
  • Oversee laboratory investigations of questionable and out of specification results
  • Manage the raw material, in-process and finished product testing operation of the Lititz Analytical and Microbiology Laboratories
  • Determine and provide the developmental needs of QC personnel within the department budget
  • Ensure adequate resources are available, including scheduling over-time as necessary to assure continued workflow
  • Assure communication of and compliance to all appropriate policies, procedures and regulatory requirements including cGMPs, WWSPs, QSPs, SOPs
  • Prepare and issue periodic reports of Laboratory performance and key events as requested
  • Direct analytical and microbiology testing of raw materials, bulk, finished goods and process water against specifications
  • Direct inspection of product containers, closure, labeling, and other product packaging materials against specifications
  • Lead and facilitate nonconformance investigations involving the Analytical Laboratory, Microbiology Laboratory, and QC Receiving Inspection
Qualifications for quality control laboratory
  • Perform QC review of laboratory study files and records to assure that calculations, content, reference, are technically correct and complete for submission for QA audit
  • Perform QC review of GLP study final reports and other high visibility final reports to assure that calculations, content, reference, are technically correct and complete for submission for QA audit
  • Coordinate with QAU staff on scheduling and quality standards for submissions for QA audit coordinating the scheduling and tracking for all quality control activities within NCD
  • Ensure compliance with FDA regulations, , 21CFR314, where the goal is inclusion in FDA animal rule submission in review of records and documents
  • Remain abreast of current FDA regulatory requirements, guidance, and current thinking to enhance the expertise and awareness of NCD staff
  • Under general supervision, coordinate and supervise the Quality Systems activities of the Instrument Calibration and Maintenance Team, the Analytical Services Team and the Laboratory Systems staff
2

Quality Control Laboratory Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality control laboratory. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality control laboratory
  • Manage the labs computerized systems, including Catalyst LIMS and Standalone instruments
  • Supervise the retain program and stability program, including Developmental Stability
  • Supervise equipment calibration and preventative maintenance
  • Manage Quality Control Capital spending through Instantis and manage method transfers
  • Establishes priorities and work schedules with other Team Leaders
  • Assure that instruments used in the test methods are calibrated, maintained and operating properly
  • Assure that chemicals, standards and reagents used in test methods have been properly labeled and are stored in a controlled environment, are within expiry date, and are prepared properly
  • Evaluate new and existing testing documents by performing required assay techniques and will develop, validate and recommend changes if needed
  • Supervises laboratory investigations, consulting with others as needed
  • Review new USP supplements and revision and report to QC Management
Qualifications for quality control laboratory
  • Review, trend, analyze, and report data, recommending appropriate action
  • Manage and may prepare and sign off on Analytical Laboratory Investigation Reports
  • Complete the ordering and maintain adequate stock of lab supplies and chemicals in con-junction with other Q.C
  • Follows all safety and environmental procedures to eliminate or minimize incidents
  • Reports non-conformances, according to established procedures and criteria, and
  • Responsible to ensure safe operation of the laboratory processes
3

Quality Control Laboratory Job Description

Job Description Example
Our growing company is looking to fill the role of quality control laboratory. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality control laboratory
  • The candidate shall perform QC review of laboratory study files and records to assure that calculations, content, reference, are technically correct and complete for submission for QA audit
  • The candidate shall perform QC review of GLP study final reports and other high visibility final reports to assure that calculations, content, reference, are technically correct and complete for submission for QA audit
  • The candidate shall coordinate and manage troubleshooting, unexpected incident investigations, and corrective action/ preventive action (CAPA) activities related to NCD-supported studies and facilities
  • The candidate shall represent Nonclinical Development Division in study and project team meetings, coordinating activities with Study Directors and study personnel
  • The candidate shall coordinate with QAU staff on scheduling and quality standards for submissions for QA audit coordinating the scheduling and tracking for all quality control activities within NCD
  • The candidate shall ensure compliance with FDA regulations, , 21CFR314, where the goal is inclusion in FDA animal rule submission in review of records and documents
  • The candidate shall apply scientific knowledge and regulatory expertise in executing assignments and assisting other supported teams
  • The candidate shall remain abreast of current FDA regulatory requirements, guidance, and current thinking to enhance the expertise and awareness of NCD staff
  • The candidate shall provide advice on, review and revise Standard Operating Procedures (SOPs), testing plans, and protocols related to laboratory testing analytical methodology and general laboratory activities
  • Provide technical, management support to ensure best lab practice and robust test methods with good repeatability to comply with the aerospace, quality and testing standards
Qualifications for quality control laboratory
  • Bachelor’s degree from an accredited institution in chemical, physical, or biological science, medical laboratory technology or medical technology required
  • Proficiency with computer systems including Microsoft Office products, LIMS, Smartlab, Empower
  • Ability to work in a laboratory environment, including wearing appropriate PPE and other safety required equipment and considerations
  • Minimum of one (1) year GMP/FDA regulated environment experience
  • Manage the day to day QC Testing laboratory operations to meet the requirements of the testing plan and ensure ‘on time’ targets are met
  • Drive continuous improvement of laboratory systems and processes through the QC laboratories, ensuring all test methods and equipment are suitably qualified and validated
4

Quality Control Laboratory Job Description

Job Description Example
Our innovative and growing company is looking for a quality control laboratory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality control laboratory
  • Liaise as required with appropriate customers and regulatory bodies
  • Recruit, train and manage a team of Technicians, ensuring that they are suitably qualified and competent to undertake various testing methods in a compliant and safe manner in accordance with the relevant approved procedures and product ranges
  • Develop the use of 5s and Lean methodologies and working practices across the Laboratories
  • Manage the review, modification and issuing of technical documentation relating to the Laboratories including IFS)
  • Oversee the commissioning and implementation of new test equipment/methods, where applicable and participate in project activities and initiatives as defined from time to time
  • Support and manage the department budget in partnership with the Quality Manager
  • Ensure repeatability and reliability (SLA) of lab results and maintain lab accreditation (control card, ring test,…)
  • In charge of individual Performance management and annual ranking of the people in the lab
  • Coordinate and harmonize the tasks of the quality assurance in the laboratory
  • Prepare and follow-up the budget of the lab
Qualifications for quality control laboratory
  • Minimum of 15 years’ experience in quality related jobs, 10 years’ experience in laboratory, with 5 years in supervision
  • Ability to handle multiple tasks/projects simultaneously and display a sense of urgency
  • Ability to work well under pressure, with minimal to no supervision, meets deadlines, and interacts with a variety of personnel and contacts
  • Ability to think and act, with minimal supervision, to make decisions
  • Knowledge of laboratory techniques and good laboratory practices
  • Thorough knowledge of regulatory requirements and limitations
5

Quality Control Laboratory Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality control laboratory. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality control laboratory
  • Perform duties in a manner that protects personal safety the safety of all personnel on site
  • Ensure that raw material, in-process, and product testing is effectively, accurately and promptly carried out using specified methods
  • Review pre-batch powders sheets for corrections or make conversions /adjustments on admixture sheets
  • Advise on corrective actions and appropriate recording methods to maintain manufactured product within specification
  • The candidate shall provide Quality Control (QC) Scientist support to the USAMRIID’s Medical Countermeasure (MCM) Advanced Test & Evaluation (T&E) capability
  • Participate on various plant teams (Safety, LORC)
  • Manage standard substances (procurement, storage, actual volume, expiration)
  • Ensuring that sampling and quality targets are achieved
  • Mentoring, coaching and developing the laboratory technician team and maintaining all equipment calibrations and certifications
  • Oversee the day-top-day operations of the QC Laboratory providing information to production for process operation and for decision making to release railcars for shipping
Qualifications for quality control laboratory
  • Experience of ERP or MRP systems and LIMS
  • Working knowledge of FDA regulated products
  • Working knowledge of validation activities for equipment
  • Associate’s or Bachelor’s degree from an accredited institution in chemical, physical, or biological science, medical laboratory technology or medical technology required
  • A tertiary qualification in science microbiology or a related field
  • High school diploma/GED with a minimum of 5 years related laboratory experience

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