Quality Assurance Associate
Benchmark Biolabs is seeking a detail-oriented Quality Assurance Associate for its scientific operations to evaluate and review laboratory, manufacturing, clinical data, QA material release, and all associated procedures to ensure compliance with applicable regulations for both internal and client requested procedures and policies.
The QA Associate will be primarily responsible for:
- Monitoring laboratory and production activities to ensure compliance with SOP’s, Outlines of Productions, and other applicable documents
- Reviewing project reports, procedures and other documentation
- Participating in internal audits of laboratory, manufacturing, facility, clinical, and document control functions of the company
- Scheduling, coordinating, participating in audits, and keeping audit records
- QA release and disposition of raw materials
- Archival of laboratory and production generated raw data
The QA Associate will assist with:
- Quality Systems training for employees
- Investigations and recommendations for corrective and preventative actions
- The development and/or upgrading of Quality Systems to assure compliance with relevant regulations
- Solving compliance problems
The QA Associate will be expected to:
- Have a basic understanding of the technology employed within the lab
- Have good communication skills and be able to reinforce requirements in a positive and professional way to colleagues at all levels within the organization
- Have a strong focus on attention to detail
- Be proficient in the use of MS Office software packages
- Be a team player
- Minimum of an Associate’s Degree in Laboratory Science field, or Bachelor’s Degree in Microbiology, Biology, Immunology, or related life science.
- At least 3-5 years experience in a life science regulated environment, preferably related to research, licensing, or commercialization of products.
Quality Control Technician – Veterinary Biologics
Benchmark Biolabs is seeking a self-starting, detail-oriented Quality Control Technician for our biological manufacturing division, Antelope Valley Bios. The Quality Control Technician performs routine microbiological and clinical tests on in-process, bulk, and final container samples of autogenous and licensed (full or conditional) veterinary biologicals. This position will work under general supervision but is expected to have working knowledge of regulations and guidance documents pertaining to veterinary biologics (9CFR, VS Memos and Notices, Supplemental Assay Methods, and Outlines of Production).
Major responsibilities for routine laboratory and clinical testing, include, but are not limited to:
- Bacteriology techniques including Gram stain, plate count, identification, preservative interference testing, sterility testing, and viable particulate monitoring
- Virology techniques including routine cell culture passage and maintenance, virus titration, proof of inactivation, hemagglutination
- Residual formaldehyde testing
- DNA quantitation, polyacrylamide gel electrophoresis, western blots
- Reagent and media preparation
- Equipment operation including but not limited to visible light and fluorescence microscopy, hemacytometer, laminar flow hood, spectrophotometry, analytical balance, pH meter, autoclave, micropipettors, incubators, freezers, and centrifuges
- Animal husbandry and observation, injection, blood collection, animal/egg ordering, egg inoculation techniques
The Quality Control Technician is expected to:
- Perform concurrent documentation of testing utilizing appropriate data collection forms or laboratory notebooks.
- Perform the reading of tests, calculation of results, and evaluation of data for conformance to specifications, and report results.
- Execute validation protocols (including but not limited to preservative interference, inactivation kinetics, and assay transfer from R&D to QC).
- Revise and update standard operating procedures as needed.
- Be proficient in aseptic technique.
- Be proficient in the use of MS Office Tools, such as Excel, Word and Outlook.
- Comply with USDA regulations as well as internal written procedures.
- Calibrate and maintain laboratory and analytical equipment.
- Assist in training new employees on quality control methods and procedures.
- Have excellent time management and organizational skills.
- Participate in a team and be able to communicate effectively with members at all levels of the organization.
- Minimum of an Associate’s Degree in Laboratory Science field, or Bachelor’s Degree in Microbiology, Biology, Immunology, or related life science.
- At least 3 years relevant laboratory experience in veterinary biological Quality Control department.
Customer Service Representative – Vaccines
Benchmark Biolabs, is seeking a motivated and self-starting Customer Service Representative, for the biological manufacturing division, Antelope Valley Bios, and sales and marketing firm, AgriLabs, in support of vaccine product lines. This position will professionally and effectively handle all customer inquiries, sales orders, and services relating to vaccine products and provide administrative support to the manufacturing division. This individual must have the desire, initiative and positive attitude to be the point person between Key Account Managers (KAM), customers, manufacturing and diagnostic lab personnel. This individual must display an energetic, can-do attitude with “smiling” phone skills who can act in a professional manner. The willingness to learn the vaccine products and required operating procedures are absolute essentials for this position.
This individual must be able to work independently, as well as a constructive team member. The ability to communicate effectively with customers and members at all levels of the organization is essential. Good documentation skills, ability to read and follow standard operating procedures, and proficiency with MS Office Tools, (Word, Excel, PP, and Outlook) is required. Valid driver license and minimal travel as requested by Supervisor for specific account responsibilities.
Minimum Educational Requirements are a High School diploma. Vet Tech or Bachelors Degree in Animal Science, Biology or related field of study strongly preferred.
Minimum of 2 years customer service experience or job-relevant position experience required.
Quality Control Manager
Benchmark Biolabs is seeking a motivated, knowledgeable Quality Control Manager for our biological manufacturing division, Antelope Valley Bios. This position will be responsible for the daily management of the AVB Quality Control team to oversee the development, implementation, and maintenance of quality control systems and laboratory activities to ensure both internal and external regulatory compliance within a USDA environment.
The Quality Control Manager will:
- Have direct oversight as well as provide hands on testing of in-process, bulk and final container samples of autogenous and licensed veterinary biologicals according to in-house Standard Test Methods (STMs) and Outlines of Production.
- Oversee data trends for the evaluation of production and QC processes, as well as the execution of validation protocols, including preservative interference, inactivation kinetics, and assay transfer from R&D to QC.
- Provide input to R&D on the development, validation and implementation of analytical methods that will be transferred to QC to support routine testing of biologics samples.
- Represent the laboratory during audits conducted by regulatory agency representatives to provide information and handle questions and/or concerns
- Perform, write, and sign-off on appropriate QC investigations of deviations
- Assists in initiatives to improve processes, cost effectiveness, enhance efficiencies, safety and compliance of processes and procedures (e.g., through improved methods, new technology, etc.).
- Be responsible for staff competency and /or training in all aspects of testing, SOPs (standard operating procedures), company policies and safety.
Our preferred candidate should:
- Have in depth knowledge of all quality control functions and responsibilities, including audits, lot release, deviation investigations, and manufacturing requirements.
- Have working knowledge of regulations and guidance for veterinary biologics.
- Portray excellent scientific analysis, interpretation, and problem solving skills.
- Have the ability to identify corrective and preventative actions
- Have the ability to forecast the departmental budget
- Have demonstrated ability to manage both projects and personnel
- Minimum of a Bachelor’s Degree in Microbiology, Biology, Immunology, or related life science.
- At least 5 years relevant experience in veterinary biologics directly interacting with R&D and Manufacturing to achieve licensing and commercialization of veterinary biologics. At least 2 years supervising/training employees in a Quality Control department are required.
Associate Scientist – Laboratory Services
Benchmark Biolabs is seeking a motivated, animal health Associate Scientist in our Laboratory Services group to contribute to the development, licensing, production, and testing of animal vaccines. This position will be responsible for assay and process development, production, and testing of master seeds and experimental serials, and the transfer of assay methods to our manufacturing division. Testing support for external clients is also required. Laboratory studies will be conducted in accordance with internal and external requirements (SOP’s, compendial methods), and this individual will need to maintain accurate laboratory notebooks to ensure compliance with regulatory and quality systems. The Associate will also develop reagents, controls, and assays needed to support laboratory studies, and will provide support to the Bioinformatics Manager when needed. Maintaining accurate inventory of assay reagents and client samples is also necessary. Some periodic weekend and/or holiday work is also required.
Our ideal candidate will have:
- Experience with mammalian cell culture techniques and standard virology methods, such as virus titration or serum neutralization testing
- Experience with development and/or qualification of in vitro assays (e.g. ELISA)
- Proficiency in conducting sterility testing in accordance with 9CFR requirements
- Strong communication and team skills, and be able to communicate effectively with co-workers at all levels of the organization.
- The ability to interact with clients at a professional level.
- Good documentation skills and detail oriented.
- Proficiency with MS Office Tools such as Word, Excel, Outlook.
Bachelor of Science Degree in Microbiology, Immunology, Biology, or related life science and a minimum of 4 years post-graduate laboratory experience in the animal health industry is required.
Equipment Calibration Technician – Facilities
Benchmark Biolabs is seeking a detail oriented and dependable Equipment Calibration Technician to ensure proper function of laboratory equipment and infrastructure. This individual will perform a variety of installation, calibration, maintenance and troubleshooting, scheduling, repair and documentation duties for laboratory, process, and utility instrumentation. This position will work closely with the Maintenance, Operations, Laboratory, and other functional groups, in biological research, development, and manufacturing environments. Development and adherence to Standard Operating Procedures, deviation processes, and quality processes will be required. The Equipment Calibration Technician is also expected to assist internal Quality Assurance and Regulatory Affairs departments in the audit response processes during facility audits by client and government agencies.
Our preferred candidate will have:
- Experience applying the knowledge, principles, and practices relevant to laboratory equipment, laboratory practices, and associated instrumentation calibration and maintenance.
- Knowledge of current Good Laboratory Practice, and familiarity with Standard Operating Procedures, guidance documents, or manuals.
- Ability to troubleshoot and work through complex problems.
- Excellent organization and prioritization skills.
- Extreme attention to detail. Accuracy in documentation.
- Teamwork and interpersonal skills. Approachable and customer service oriented.
- Demonstrated proficiency in Microsoft Word, Excel, Outlook email or other web based applications. Calibration Manager or other calibration/maintenance software familiarity preferred.
- A sense of urgency, dependability, and integrity. In special circumstances incumbent may be needed beyond the scope of the standard workweek to perform additional services to ensure successful business operations.
Associate Degree or equivalent Vocational, Technical, or Military training with a minimum of 2 years industrial experience in specified skill areas, or 5-7 years demonstrated industrial experience in specified skill areas regardless of educational background.
Benchmark Biolabs offers an excellent benefit package and an outstanding work environment. To be considered, e-mail cover letter and résumé, along with salary requirements, to: email@example.com or mail to Benchmark Biolabs/Attn: Human Resources/421 West Industrial Lake Drive/Lincoln, NE/68528
About the Company:
AgriLabs® is a leader in biological innovation for animal health in the United States. Through proprietary DNA platform and adjuvant technologies, AgriLabs is delivering the next generation of vaccine solutions for farm animals. These technologies – combined with other innovative products and the leading distribution network in the United States – uniquely position AgriLabs to improve animal health, nutrition and productivity.
Benchmark Biolabs is a leader in animal biologics contract research in the United States and around the globe. A member of the AgriLabs® family of companies, Benchmark has an extraordinary track record of research and regulatory firsts. Through expert, confidential and responsive services, Benchmark helps speed the biological innovation process from concept to commercialization.
VaxLiant®, a member of the AgriLabs® family of companies, develops and markets innovative adjuvant technologies that optimize vaccine performance. Through a portfolio that includes ready-to-use ENABL® adjuvants and fully customizable BioMize adjuvants, VaxLiant enhances traditional and DNA platform vaccines that improve animal health and productivity.
Antelope Valley Bios
Antelope Valley Bios, a member of the AgriLabs® family of companies, provides contract manufacturing services for animal vaccines. Through a new, state-of-the-art USDA-licensed facility, Antelope Valley Bios produces biological products that meet the highest levels of quality and efficiency for a wide range of start-ups and established global companies.