Human Resources Manager

We are looking for a motivated Human Resources Manager to oversee the HR responsibilities of our dynamic and rapidly growing business.

The ideal candidate will have experience as a Human Resources generalist and will have a thorough knowledge of HR principles. Primary responsibilities include development, implementation, and administration of the HR functions, recruiting and retaining diverse employee talent, prepare payroll for bi-monthly payroll processing, and benefits administration.

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Quality Control Associate/Scientist

Immediate opening for Quality Control Associate/Scientist with strong proficiency in developing, optimizing, and validating analytical assays, such as ELISAs, qRT-PCR, or microbiological assays, preferably in a cGMP or QC environment.

The Quality Control Associate/Scientist will have a proven ability to troubleshoot and solve problems with assays both during development and routine work, and extensive experience in several of the following: writing technical reports, validation reports and SOPs, release and stability testing for pharmaceutical products, environmental monitoring, aseptic environment, analytical instrument IQ/OQ/PQ and calibration. The successful candidate will have a PhD in Chemistry, Biology, Biomedical, Pharmaceutical Sciences or related field with 1 – 3 years of work experience, or a Master’s degree with 3+ years of work experience, in pharmaceutical or biotech industry analytical laboratories. Quality Control Laboratory experience in support of GMP/GLP strongly preferred.

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Quality Control Associate

Immediate opening for Quality Control Associate with hands on, industry experience in running and validating analytical assays such as HPLC, capillary isoelectric focusing, or capillary electrophoresis, preferably in a cGMP or QC environment.

The Quality Control Associate will have a proven ability to troubleshoot and solve problems with assays both during development and routine work. They should have experience in areas such as writing technical reports, stability testing, environmental monitoring, aseptic environment, and instrument calibration.

The successful candidate will have a Master’s degree in Chemistry, Biology, Biomedical, Pharmaceutical Sciences or related field with 1 – 3 years of work experience, or a Bachelor’s degree with 2 – 4 years of work experience, in pharmaceutical or biotech industry analytical laboratories. Quality Control Laboratory experience in support of GMP/GLP strongly preferred.

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Pharmaceutical – Quality Assurance Specialist 

Immediate opening for Pharmaceutical – Quality Assurance Specialist with demonstrated in-depth knowledge, proficiency, and experience in Quality Systems/QA activities in regulated pharmaceutical environment. The Pharmaceutical QA Specialist will establish QA procedures, write SOPs, identify and resolve Quality problems in GMP/GLP, investigate and report deviations, conduct quality inspections, and implement document management and control.

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Quality Assurance Specialist/Associate

Two immediate openings for Quality Assurance (QA) Specialists/Associates with demonstrated proficiency in quality systems/QA activities in regulated pharmaceutical environment.

The QA Specialists/Associates will perform QA review of controlled documents, write SOPs, establish QA procedures, coordinate quality activities, identify and resolve quality problems in GMP/GLP, assist in conducting routine inspections, establish and implement document management and control activities.

The successful candidate will have a master’s degree or bachelor’s degree in life sciences; 1-5 years of work experience in pharmaceutical or biotech industries; a minimum of 1 year of QA experience in support of GMP/GLP. Knowledge of FDA, EMEA and other applicable industry and quality regulations related to pharmaceutical industry is required. Proficiency and knowledge in quality system operations and applicable regulations related to GXP is preferred.

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Quality Assurance-Document Control Intern

We are looking for a Quality Assurance-Document Control Intern to contribute to the Akston Biosciences QA team by assisting with documentation management activities, logbook management to support our GMP manufacturing facility and Quality Control lab, and performing data analysis/trending of quality metrics.

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