The Quality Control Chemist (QCC) reports to Quality Control (QC) Management.
The QCC will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Chemistry Laboratory complies in the areas of analytical applications, release specifications, and documentation practices.
The QCC will assist in evaluating new testing applications and instrumentation, either developing methods or adopting compendial methods. This person will aid in transferring these new methods into a Quality Control function for routine use. The QCC will ensure at the least, these methods are accurate, precise, and robust for daily use on specific samples.
The QCC will assist in the purchase and commission of analytical instrumentation. This person will aid in developing purchasing and comparison strategies to ensure the most applicable analytical technology is fit for the purpose. The QCC will work with Management in scheduling of service technicians and outside contractors for set up/PM/calibrations.
The QCC will track and coordinate all laboratory calibration events. The Chemist will work closely with the Calibration Coordinator in determining the type of calibration needed and the frequencies for all laboratory instrumentation. The QCC will ensure all calibration work has been properly documented and archived according to procedure and all deviations are justified appropriately.
The QCC will assist the laboratory personnel in resolving Out of Specification (OOS) results in the QC Laboratory. The Chemist will ensure the proper use of the analytical instrumentation and there are no malfunctions causing the OOS result. The QCC will ensure there are no other interferences coming from the product formulations causing the OOS result.
The QCC will assist in training new laboratory personnel. All training performed under the supervision of the QCC will be documented in accordance with established SOPs and the Nutramax training program.
The QCC will follow Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion. The QCC will maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
The QCC should be able to handle specific QC projects and other necessary functions.
Perform other assigned duties as may be required in meeting company objectives.
Communicate effectively with other departments within the organization and function within a team environment.
Minimum Requirements : The QCC will have three or more years of laboratory experience in a cGMP facility, including experience with operation of laboratory instrumentation including Gas Chromatography (GC) and/or Liquid Chromatography (LC) required, troubleshooting, generation and revision of SOPs and test methods. Effective interpersonal, self-motivation skills, and the ability to interact with all levels of personnel are required.
Education and Experience: A Bachelor of Sciences (B.S.) or Bachelor of Arts (B.A.) degree in Chemistry or a related science is required for the QCC position.
[post_title] => QC Chemist or Analyst - 2nd Shift
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[post_content] => Summary of the Position: The Quality Control Microbiology Technician (QCMT) reports to Quality Control (QC) Management
Roles and Responsibilities:
The QCMT will be responsible for the general organization, cleanliness, and upkeep of the QC Microbiology Laboratories.
The QCMT will manage all microbiological samples for retention, in-house testing, and disposition to contract laboratories for additional testing. (S) he will also prepare samples for both in-house and outside analyses and deliver samples to the Shipping Department as appropriate for shipment to contract laboratories.
The QCMT will conduct entry-level laboratory functions such as the preparation of media, daily performance check of analytical balances.
The QCMT will perform LIMS functions as appropriate including but not limited to sample entry, sample receipt, and data entry.
The QCMT will be responsible for the ordering and inventory of office supplies, lab supplies, media and reagents in the QC Microbiology Laboratories.
The QCMT will be responsible for growth promotion and/or preparation of media and control plates for routing testing.
The QCMT will provide input for the improvement or revision of Standard Operating Procedures (SOPs), Finished Product Specifications, and Raw Material Specifications, as appropriate.
The QCMT will be responsible for the labeling and organization of all QC files, including the packing of documents for warehouse or off-site storage. (S)he will also assist QC Analysts and the QC Supervisor with additional filing, scanning, or other clerical duties as needed.
The QCMT will keep the QC Microbiology Laboratories supplied with clean glassware. (S)he will be proficient in the operation of the automated glassware dishwasher and laboratory autoclave.
The QCMT will maintain a safe working environment by following all laboratory safety guidelines and wearing Personal Protective Equipment (PPE) as appropriate. The QCMT will ensure that all equipment used in testing procedures is calibrated and properly maintained.
The QCMT will lead the collection of Environmental Monitoring samples, throughout the facilities, following SOP's on a monthly basis, as needed to meet the needs or goals of the company. The QCMT will be familiar with the operation of both the APC Airborne particle counter and the SAS air sampler. And will be proficient in the use and handling of media plates and swabs for EM sampling. The QCMT is responsible for the scrutiny, documentation, and interpretation of EM results. The QCMT must communicate EM trends and findings to QC, Manufacturing or Packaging management as appropriate.
The QCMT will be responsible for sampling water throughout the facilities and performance of routine testing, as part of Environmental Monitoring.
Perform other assigned duties as may be required in meeting company objectives.
Communicate effectively with other departments within the organization and function within a team environment.
Minimum Requirements: Prior microbiology experience is highly preferred. Effective interpersonal skills and the ability to interact with all levels of personnel are required.
Education and Experience: A high school diploma or General Educational Development (GED) credential are required for the QCMT position.
[post_title] => Microbiology Technician
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[post_date] => 2021-03-23 13:46:31
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[post_content] => Summary of the Position:
The Laboratory Calibration Technician will be responsible for performing scheduled and unscheduled qualifications, calibration, preventative maintenance, and repair tasks in support of typical analytical and process instrumentation used in the laboratory for Nutramax in South Carolina and Maryland facilities
Roles and Responsibilities:
Performs both scheduled and unscheduled calibration, preventive maintenance, and repair tasks for moderately complex laboratory and process instrumentation.
Support equipment and instrumentation including but not limited to: HPLC (High Performance Liquid Chromatography) Systems, GCs (Gas Chromatography), temperature and pressure measuring instruments, hardness testers, balances, furnaces, ovens, autoclaves, glassware washers, stability chambers/ incubators, liquid-in-glass and digital thermometers, thermocouples / RTD's, humidity sensors, spectrophotometers, refractometers, pipettes, pH/conductivity/resistivity instruments, and an array of other laboratory, production and packaging equipment
Documents calibration results in the calibration management system database (LIMS).
Plans, schedules and performs monthly workload assignments; including devotion of time to effectively manage on-demand assignments as they arise.
Works closely with equipment users, engineers and other technicians in the process of getting monthly work completed
Troubleshoot and repair laboratory instruments (HPLC/GC/LCMS) for assay related issues: irregular pressure traces, low assay counts, retention rates, and reagents.
Interfaces and communicates effectively with direct Supervisors/ Management, various levels of personnel within the company and with external manufacturers/suppliers/service vendors.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Act as liaison with outside contractors and vendors for equipment repairs or contract maintenance.
Responsible for managing PM, repairs, and calibration records for all equipment and instruments in both facilities.
Perform other assigned duties as may be required in meeting company objectives
Communicate effectively with other departments within the organization and function within a team environment.
Regular attendance is required
Minimum Requirements:
A minimum of three years of field experience and familiarity with Quality systems, including proper operation of laboratory instrumentations, troubleshooting, and the generation and revision of SOPs. Effective interpersonal skills and the ability to interact with all levels of personnel are required. A strong proficiency in MS office and metrology database applications is also required
Education and Experience:
A Bachelor of Science degree is preferred.
Minimum of a two-year degree in a technical discipline (A.S. or A.A.S.), or equivalent military education (60-credit hours) and training, (ASQ Calibration Technician Certification (CCT) and/or military PMEL training is a plus, but not mandatory)
3-5 years previous calibration/instrumentation experience is
Troubleshooting, repairing, qualifying and calibrating HPLC (high performance liquid chromatography) and GC (gas chromatography) systems is required.
Previous experience working in a GMP environment
Excellent communication skills, both written and verbal; commitment to timely follow-up/response
Position Summary: Creates new tapes for local markets. Identifies new markets for existing Coroplast tapes. Develops tapes that correspond to quality specifications in collaboration with possible local suppliers and/or customers and in agreement with Corporate R&D. Coordinates national F&E tape related activities in agreement with Corporate R&D.
Requirements
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Assists local customers and Coroplast sales department with technical inquiries related to tapes for industry and manufacturing sectors.
Analyzes raw materials from local suppliers regarding their use for tapes.
Consults with local attorneys in respect to patent laws
Reviews, documents, and reports local areas of competition and technology as they related to tapes
Initiates the use of synergies between companies in the Coroplast group
Generates ideas for innovative tapes on a local and international basis
Directs necessary processes on an international basis. Also directs collaboration with external and internal partners, if necessary
Analyzes, I collaboration with the sales department, the exact requirements of local products to be developed
Produces specifications of raw materials for tapes to suppliers in close collaboration with Corporate Quality
Develops and analyzes new local markets
Participates, in close collaboration with Corporate Quality, in the creation of test plans/procedures in quality control for production of tapes
Participates in the creation and extension of local R&D laboratories and facilities in collaboration with Corporate R&D
Other tasks as required/assigned
Competencies: To perform the job successfully, an individual should demonstrate the following:
Adaptability - Demonstrates persistence and overcomes obstacles. Measures self against standard of excellence. Recognizes and acts on opportunities. Sets and achieves challenging goals. Takes calculated risks to accomplish goals.
Communications - Exhibits good listening and comprehension. Expresses ideas and thoughts in written form. Expresses ideas and thoughts verbally. Keeps others adequately informed. Selects and uses appropriate communication methods.
Continuous Learning - Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
Customer Service – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
Problem Solving - Develops alternative solutions. Gathers and analyzes information skillfully. Identifies problems in a timely manner. Resolves problems in early stages. Works well in group problem solving situations.
Teamwork - Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Puts success of team above own interests.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience:
Doctorate Degree in Chemistry and five to ten years related experience.
Language Ability:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Ability:
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Reasoning Ability:
Ability to define problems, collect data, establish facts, draw valid conclusions and report thereon. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Computer Skills:
To perform this job successfully, an individual should have advanced level of knowledge with Microsoft Office 365 and Accounting (SAP) software.
Certificates and Licenses:
No certifications needed.
Supervisory Responsibilities: None at this time, potentially a group of lab technicians.
Work Environment: 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. The noise level in the work environment is usually moderate.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform 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 is regularly required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear and taste or smell. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 50 pounds, carry up to 25 pounds, push and pull occasionally up to 25 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and ability to adjust focus.
