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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Maintenance Mechanic II – GMP Facilities

The Maintenance Mechanic will ensure the efficient maintenance and reliable operation of the process and utility equipment needed to support a GMP manufacturing facility, including supporting laboratories.  He or she will also supervise service providers that support GMP operations including, but not limited to, cleaning contractors, gowning vendors, gas supply vendors, utility providers, etc.

The successful candidate will have a High School diploma or equivalent plus 3 to 5 years of related industry experience or a relevant Associates Degree in the Life Science/Engineering field, with 2 to 4 years of cGMP plant operations experience.

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Senior Quality Assurance Specialist

Immediate opening for Senior Quality Assurance (QA) Specialist with demonstrated in-depth knowledge, proficiency, and experience in Quality Systems/QA activities in regulated pharmaceutical environment.

The Senior QA Specialist will establish QA procedures, implement document management and control activities, perform QA review of controlled documents, write SOPs and additional quality system documents, identify and resolve quality problems in GMP/GLP, investigate, and report deviations and help implement CAPA tools, establish procedures for change control process, conduct quality inspections and internal audits, assist in risk analysis and risk management procedures, monitor equipment and facility management procedures to ensure quality compliance.

The successful candidate will have amaster’s degree or bachelor’s degree in life sciences; 5-10 years of work experience in pharmaceutical or biotech industries; a minimum of 4 year of QA experience in support of GMP/GLP is required. Knowledge of FDA, EMEA and other applicable industry and quality regulations related to pharmaceutical industry is required. Formal training and expertise in Quality Systems or QA operations and applicable regulations is highly desirable.

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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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