QC Microbiology Associate I - Astellas Pharma
Westborough, MA
About the Job
QC Microbiology Associate I
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a QC Microbiology Associate I opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
AIRM is seeking a highly motivated individual to join us as a QC Microbiology Associate I. This position provides Quality Control Microbiology support to all aspects of a GMP environmental monitoring program and product testing. Looking for experience with environmental monitoring in a GMP setting. Ability/Flexibility to work evenings and weekends is required.
Essential Job Responsibilities:
+ Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas/cleanrooms.
+ Perform testing for gram staining, microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation.
+ Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities.
+ Receive samples for analysis, ship samples for contract lab testing, enter/review data, and
+ organize data according to cGDP/GMP requirements.
+ Revise SOPs/forms, Initiate incident reports and deviations for OOS results -support root cause analysis for EM excursions.
+ Assist in EM data review for trending and other technical documentation or projects.
+ Perform lab set up, house keeping/routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance to cGLP/GMP.
Quantitative Dimensions:
+ This position interacts with QC, QA and Manufacturing personnel and management.
Organizational Context:
+ Reporting to QC Microbiology Manager.
Qualifications:
Required:
+ Bachelor’s Degree in biology, microbiology or related life science with 0-3 years’ relevant GMP/pharma/microbiology laboratory experience
+ Ability/Flexibility to work evenings and weekends/holidays is required- to support manufacturing operations
+ Good knowledge of Aseptic technique and common microbiological testing
+ Knowledge of relevant, compliance and guidance documents, documentation (ALCOA +) and data organization
+ Must be able to gown into cleanrooms in support of testing and manufacturing activities
+ Detail oriented, willingness to learn and follow instructions
+ Interpersonal skills and ability to contribute to the success of a team
Preferred:
+ Experience of working in a fast-paced team environment, time management, and meet deadlines.
+ Team player with the ability and willingness to support other colleagues in the Quality Control department.
+ Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
+ Organization and completion of assay documentation and entering data into QC database.
+ Write, revise and review Standard Operating Procedures and Forms.
+ Lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
+ Assist in conducting and documenting laboratory investigations.
+ Participates in facility start-up, commissioning, and validation activities.
+ Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.
+ Perform other lab duties as required.
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-LK
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
Astellas Institute for Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a QC Microbiology Associate I opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
AIRM is seeking a highly motivated individual to join us as a QC Microbiology Associate I. This position provides Quality Control Microbiology support to all aspects of a GMP environmental monitoring program and product testing. Looking for experience with environmental monitoring in a GMP setting. Ability/Flexibility to work evenings and weekends is required.
Essential Job Responsibilities:
+ Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas/cleanrooms.
+ Perform testing for gram staining, microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation.
+ Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities.
+ Receive samples for analysis, ship samples for contract lab testing, enter/review data, and
+ organize data according to cGDP/GMP requirements.
+ Revise SOPs/forms, Initiate incident reports and deviations for OOS results -support root cause analysis for EM excursions.
+ Assist in EM data review for trending and other technical documentation or projects.
+ Perform lab set up, house keeping/routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance to cGLP/GMP.
Quantitative Dimensions:
+ This position interacts with QC, QA and Manufacturing personnel and management.
Organizational Context:
+ Reporting to QC Microbiology Manager.
Qualifications:
Required:
+ Bachelor’s Degree in biology, microbiology or related life science with 0-3 years’ relevant GMP/pharma/microbiology laboratory experience
+ Ability/Flexibility to work evenings and weekends/holidays is required- to support manufacturing operations
+ Good knowledge of Aseptic technique and common microbiological testing
+ Knowledge of relevant, compliance and guidance documents, documentation (ALCOA +) and data organization
+ Must be able to gown into cleanrooms in support of testing and manufacturing activities
+ Detail oriented, willingness to learn and follow instructions
+ Interpersonal skills and ability to contribute to the success of a team
Preferred:
+ Experience of working in a fast-paced team environment, time management, and meet deadlines.
+ Team player with the ability and willingness to support other colleagues in the Quality Control department.
+ Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted
+ Organization and completion of assay documentation and entering data into QC database.
+ Write, revise and review Standard Operating Procedures and Forms.
+ Lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
+ Assist in conducting and documenting laboratory investigations.
+ Participates in facility start-up, commissioning, and validation activities.
+ Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.
+ Perform other lab duties as required.
Benefits:
+ Medical, Dental and Vision Insurance
+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
+ 401(k) match and annual company contribution
+ Company paid life insurance
+ Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
+ Long Term Incentive Plan for eligible positions
+ Referral bonus program
#LI-LK
Category Massachusetts TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Source : Astellas Pharma