Recipharm
Quality Control Analyst III
Recipharm - Boston, Massachusetts, us, 02298
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Overview
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Quality Control Analyst III
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Recipharm Continue with Google Continue with Google 3 days ago Be among the first 25 applicants Join to apply for the
Quality Control Analyst III
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Recipharm About The Role
Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.
The Quality Control Analyst III will primarily be responsible for supporting and leading late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through activities such as raw material testing, release testing, stability testing, and environmental monitoring. This team member will also initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices. About The Role
The Quality Control Analyst III will primarily be responsible for supporting and leading late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through activities such as raw material testing, release testing, stability testing, and environmental monitoring. This team member will also initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices.
Main Tasks & Responsibilities
Actively participate in fostering a positive, collaborative work culture. Author and revise standard operating procedures, test methods, protocols, and reports. Execute raw material testing, stability testing, method qualifications, technical transfers, release testing, and method validations. Test materials using methods such as UPLC, LC-MS, GC, CE, FTIR, qPCR, ELISA, Karl Fischer, SDS-PAGE, bacterial enumeration, bacterial endotoxin, and bioburden. Analyze and review data. Initiate and participate in laboratory investigations, including deviations and out-of-specifications. Perform equipment calibrations and analyze cell viability. Execute method and equipment troubleshooting and optimization as needed. Maintain documentation in accordance with GDP. Other duties as assigned.
Skills & Experience
S. degree in science or a life science-related field. 5+ years of experience in Quality Control in a GMP environment, preferably with experience with UPLC/ HPLC. Experience with instrumentation such as HPLC, ELISA, and isolators. Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g., pH meters and balances). Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH). Experience with writing standard operating procedures. Familiarity with FDA, ICH, and EU Regulations and Guidelines. Involvement in continuous improvement initiatives and laboratory investigations. Experience in a Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) is desirable. Proficiency in Microsoft Office suite applications.
What We Offer/Employee Benefits
Medical Benefits: Medical, Dental, Vision, Life, AD&D Insurance, Disability, FSA, HSA, Additional Voluntary Plans 401K Match Time off: PTO, sick time, floating holidays, and 9 company holidays
LOCATION
Watertown, MA
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.
Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.
For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com
URL to this page https://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3563&rmlang=UKSeniority level
Seniority levelNot Applicable Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Recipharm by 2x Sign in to set job alerts for “Quality Control Analyst” roles. Continue with Google Continue with Google Continue with Google Continue with Google Quality Control Analyst II - Raw MaterialsAssociate Director / Director, Quality ControlQuality Control Aerospace Manufacturing (Multiple shifts)Senior Analyst I, Quality Control ChemistryQA Specialist II, Validation, Contractor Lexington, MA $86,500.00 - $135,960.00 2 days ago Boston, MA $75,000.00 - $95,000.00 2 months ago Quality Control Specialist- Gas Operations Somerville, MA $92,820.00 - $103,130.00 5 days ago Quality Control Specialist- Gas Operations Boston, MA $92,820.00 - $103,130.00 5 days ago Boston, MA $71,453.20 - $102,351.00 1 month ago Lexington, MA $86,500 - $135,960 18 hours ago Non Clinical Quality Control Reviewer II Cambridge, MA $67,151 - $79,460 1 week ago Associate Auditor, Design Quality AssuranceAssociate Director, Quality Control - Stabili We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Quality Control Analyst III
role at
Recipharm Continue with Google Continue with Google 3 days ago Be among the first 25 applicants Join to apply for the
Quality Control Analyst III
role at
Recipharm About The Role
Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below.
The Quality Control Analyst III will primarily be responsible for supporting and leading late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through activities such as raw material testing, release testing, stability testing, and environmental monitoring. This team member will also initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices. About The Role
The Quality Control Analyst III will primarily be responsible for supporting and leading late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through activities such as raw material testing, release testing, stability testing, and environmental monitoring. This team member will also initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices.
Main Tasks & Responsibilities
Actively participate in fostering a positive, collaborative work culture. Author and revise standard operating procedures, test methods, protocols, and reports. Execute raw material testing, stability testing, method qualifications, technical transfers, release testing, and method validations. Test materials using methods such as UPLC, LC-MS, GC, CE, FTIR, qPCR, ELISA, Karl Fischer, SDS-PAGE, bacterial enumeration, bacterial endotoxin, and bioburden. Analyze and review data. Initiate and participate in laboratory investigations, including deviations and out-of-specifications. Perform equipment calibrations and analyze cell viability. Execute method and equipment troubleshooting and optimization as needed. Maintain documentation in accordance with GDP. Other duties as assigned.
Skills & Experience
S. degree in science or a life science-related field. 5+ years of experience in Quality Control in a GMP environment, preferably with experience with UPLC/ HPLC. Experience with instrumentation such as HPLC, ELISA, and isolators. Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g., pH meters and balances). Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH). Experience with writing standard operating procedures. Familiarity with FDA, ICH, and EU Regulations and Guidelines. Involvement in continuous improvement initiatives and laboratory investigations. Experience in a Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) is desirable. Proficiency in Microsoft Office suite applications.
What We Offer/Employee Benefits
Medical Benefits: Medical, Dental, Vision, Life, AD&D Insurance, Disability, FSA, HSA, Additional Voluntary Plans 401K Match Time off: PTO, sick time, floating holidays, and 9 company holidays
LOCATION
Watertown, MA
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.
Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.
For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com
URL to this page https://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3563&rmlang=UKSeniority level
Seniority levelNot Applicable Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Recipharm by 2x Sign in to set job alerts for “Quality Control Analyst” roles. Continue with Google Continue with Google Continue with Google Continue with Google Quality Control Analyst II - Raw MaterialsAssociate Director / Director, Quality ControlQuality Control Aerospace Manufacturing (Multiple shifts)Senior Analyst I, Quality Control ChemistryQA Specialist II, Validation, Contractor Lexington, MA $86,500.00 - $135,960.00 2 days ago Boston, MA $75,000.00 - $95,000.00 2 months ago Quality Control Specialist- Gas Operations Somerville, MA $92,820.00 - $103,130.00 5 days ago Quality Control Specialist- Gas Operations Boston, MA $92,820.00 - $103,130.00 5 days ago Boston, MA $71,453.20 - $102,351.00 1 month ago Lexington, MA $86,500 - $135,960 18 hours ago Non Clinical Quality Control Reviewer II Cambridge, MA $67,151 - $79,460 1 week ago Associate Auditor, Design Quality AssuranceAssociate Director, Quality Control - Stabili We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr