QC Raw Material, Analyst III (BIO/PHARMA)
Quick Apply Full-time 7 hours ago Full Job Description RELOCATION TO BALTIMORE, MARYLAND METRO AREA IS REQUIRED! (ASSISTANCE PROVIDED) This Permanent Full-Time Position offers fantastic working culture and an exceptionally competitive compensation package.
QC Raw Material, Analyst III (BIO/PHARMA) PharmAllies is working alongside a leading innovative pharmaceutical, biopharma, and biotechnology manufacturing company to source talented and experienced professionals whose specialty is within the life science industry.
Salaries are very competitive, and the company culture is nurturing, collaborative, and rewarding.
Consider joining a company that provides lifesaving medicines to protect and improve lives.
Make a difference; apply today! SUMMARY The QC Raw Material, Analyst III position will be subject matter expert in performing methods and procedures for inspecting, testing, and evaluating raw materials.
They streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities.
They also support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other Company sites.
Conduct out-of-specification and failure investigations, recommend, and implement corrective actions.
Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department.
RESPONSIBILITIES Guides change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Assists the implementation of the raw material program at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
Reviews compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Execute entering sample and result of raw materials into Lims Lab Vantage system.
Experienced in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.
Coordinate and communicate with third parties and/or other departments.
Ships samples and monitors test results produced by contract testing laboratories.
Readies SOPs, specifications, and method verification protocols and reports.
Communicates with raw material manufacturers to implement testing methodologies at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.
Handles wet chemistry, chromatographic, and spectroscopic testing.
Executes required data analysis, compiles data, and prepares results for review Guides Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.
Participates in raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
Executes other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
EDUCATION, PROFESSIONAL EXPERIENCES AND SKILLS Bachelor's Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience.
(Mainly QC Raw Material background) Familiarity with global pharmacopeias and monograph testing.
Experience with spectroscopic methods, chromatography, and wet chemistry methods.
Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.
Ability to follow SOPs and comply with cGMPs; generate SOPs.
Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
Experience working in a pharmaceutical testing environment.
Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.
Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.
Comprehensive knowledge of pharmaceutical GLPs and GMPs.
Proficient in Microsoft Office - Word, Excel, PowerPoint.
Comprehensive knowledge of regulatory/industry guidance.
Comprehensive knowledge of laboratory techniques and safety precautions.
E23-00009 Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Paid time off Parental leave Relocation assistance Vision insurance Schedule:
8 hour shift Application Question(s):
Will you be able to commute or relocate to MARYLAND for this job? Will you now, or in the future, require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case? Education:
Bachelor's (Required)
Experience:
QC Raw Materials:
5 years (Required) pharmaceutical testing environment:
5 years (Required) Work Location:
One location Guides change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Assists the implementation of the raw material program at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
Reviews compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Execute entering sample and result of raw materials into Lims Lab Vantage system.
Experienced in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.
Coordinate and communicate with third parties and/or other departments.
Ships samples and monitors test results produced by contract testing laboratories.
Readies SOPs, specifications, and method verification protocols and reports.
Communicates with raw material manufacturers to implement testing methodologies at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.
Handles wet chemistry, chromatographic, and spectroscopic testing.
Executes required data analysis, compiles data, and prepares results for review Guides Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.
Participates in raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
Executes other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
Bachelor's Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience.
(Mainly QC Raw Material background) Familiarity with global pharmacopeias and monograph testing.
Experience with spectroscopic methods, chromatography, and wet chemistry methods.
Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.
Ability to follow SOPs and comply with cGMPs; generate SOPs.
Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
Experience working in a pharmaceutical testing environment.
Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.
Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.
Comprehensive knowledge of pharmaceutical GLPs and GMPs.
Proficient in Microsoft Office - Word, Excel, PowerPoint.
Comprehensive knowledge of regulatory/industry guidance.
Comprehensive knowledge of laboratory techniques and safety precautions.
401(k) 401(k) matching Dental insurance Health insurance Paid time off Parental leave Relocation assistance Vision insurance 8 hour shift Will you be able to commute or relocate to MARYLAND for this job? Will you now, or in the future, require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case? Bachelor's (Required) QC Raw Materials:
5 years (Required) pharmaceutical testing environment:
5 years (Required) Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
QC Raw Material, Analyst III (BIO/PHARMA) PharmAllies is working alongside a leading innovative pharmaceutical, biopharma, and biotechnology manufacturing company to source talented and experienced professionals whose specialty is within the life science industry.
Salaries are very competitive, and the company culture is nurturing, collaborative, and rewarding.
Consider joining a company that provides lifesaving medicines to protect and improve lives.
Make a difference; apply today! SUMMARY The QC Raw Material, Analyst III position will be subject matter expert in performing methods and procedures for inspecting, testing, and evaluating raw materials.
They streamline and improve compliance and efficiency in Quality Control programs and develop, implement, and maintain quality control systems and activities.
They also support program improvements including SOPs, new test methods, improved specifications, raw material qualification program, and alignment of raw material procurement with other Company sites.
Conduct out-of-specification and failure investigations, recommend, and implement corrective actions.
Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department.
RESPONSIBILITIES Guides change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Assists the implementation of the raw material program at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
Reviews compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Execute entering sample and result of raw materials into Lims Lab Vantage system.
Experienced in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.
Coordinate and communicate with third parties and/or other departments.
Ships samples and monitors test results produced by contract testing laboratories.
Readies SOPs, specifications, and method verification protocols and reports.
Communicates with raw material manufacturers to implement testing methodologies at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.
Handles wet chemistry, chromatographic, and spectroscopic testing.
Executes required data analysis, compiles data, and prepares results for review Guides Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.
Participates in raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
Executes other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
EDUCATION, PROFESSIONAL EXPERIENCES AND SKILLS Bachelor's Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience.
(Mainly QC Raw Material background) Familiarity with global pharmacopeias and monograph testing.
Experience with spectroscopic methods, chromatography, and wet chemistry methods.
Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.
Ability to follow SOPs and comply with cGMPs; generate SOPs.
Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
Experience working in a pharmaceutical testing environment.
Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.
Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.
Comprehensive knowledge of pharmaceutical GLPs and GMPs.
Proficient in Microsoft Office - Word, Excel, PowerPoint.
Comprehensive knowledge of regulatory/industry guidance.
Comprehensive knowledge of laboratory techniques and safety precautions.
E23-00009 Job Type:
Full-time
Benefits:
401(k) 401(k) matching Dental insurance Health insurance Paid time off Parental leave Relocation assistance Vision insurance Schedule:
8 hour shift Application Question(s):
Will you be able to commute or relocate to MARYLAND for this job? Will you now, or in the future, require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case? Education:
Bachelor's (Required)
Experience:
QC Raw Materials:
5 years (Required) pharmaceutical testing environment:
5 years (Required) Work Location:
One location Guides change for revision of existing tests and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Assists the implementation of the raw material program at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning lab(weekly/monthly).
Reviews compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
Execute entering sample and result of raw materials into Lims Lab Vantage system.
Experienced in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, AKTA, HPLC and GC.
Coordinate and communicate with third parties and/or other departments.
Ships samples and monitors test results produced by contract testing laboratories.
Readies SOPs, specifications, and method verification protocols and reports.
Communicates with raw material manufacturers to implement testing methodologies at Company.
Executes daily activities in routine sampling raw materials, testing of raw materials and cleaning samples.
Handles wet chemistry, chromatographic, and spectroscopic testing.
Executes required data analysis, compiles data, and prepares results for review Guides Period Review, OOS, deviations, Change Control, and CAPAs; designs and implements corrective action plans to address deficiencies.
Participates in raw material testing equipment and instrument qualification, calibration, and preventive maintenance, as assigned.
Executes other duties as assigned in support of QC Laboratory operations such as facilities qualification and routine monitoring testing, as well as QC testing, data reviews, sampling, and maintaining QC laboratory systems, when appropriately trained and qualified.
Bachelor's Degree in Chemistry or closely related scientific discipline with at least 5 years of relevant experience or Master's Degree with a minimum of 3 years of relevant experience.
(Mainly QC Raw Material background) Familiarity with global pharmacopeias and monograph testing.
Experience with spectroscopic methods, chromatography, and wet chemistry methods.
Experience with implementing compendial test methods and performing a variety of analyses including computer-based instrumental analytics.
Ability to follow SOPs and comply with cGMPs; generate SOPs.
Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
Experience working in a pharmaceutical testing environment.
Requires the ability to execute raw material assay methodologies including spectroscopy, wet chemistry, and chromatography.
Requires good technical writing skills and the ability to effectively communicate with manufacturing, materials management, and quality assurance staff.
Comprehensive knowledge of pharmaceutical GLPs and GMPs.
Proficient in Microsoft Office - Word, Excel, PowerPoint.
Comprehensive knowledge of regulatory/industry guidance.
Comprehensive knowledge of laboratory techniques and safety precautions.
401(k) 401(k) matching Dental insurance Health insurance Paid time off Parental leave Relocation assistance Vision insurance 8 hour shift Will you be able to commute or relocate to MARYLAND for this job? Will you now, or in the future, require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case? Bachelor's (Required) QC Raw Materials:
5 years (Required) pharmaceutical testing environment:
5 years (Required) Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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