Software Guidance & Assistance, Inc. (SGA, Inc.)
Quality Assurance Specialist
Software Guidance & Assistance, Inc. (SGA, Inc.), Boston, Massachusetts, us, 02298
18 hours ago Be among the first 25 applicants
Software Guidance & Assistance, Inc. (SGA, Inc.) provided pay range This range is provided by Software Guidance & Assistance, Inc. (SGA, Inc.). Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $50.00/hr - $55.00/hr
Direct message the job poster from Software Guidance & Assistance, Inc. (SGA, Inc.)
Software Guidance & Assistance, Inc., (SGA), is searching for a
Quality Assurance Specialist
for a
contract
assignment with one of our premier BioTech services clients in
Boston, MA .
Learn more about the general tasks related to this opportunity below, as well as required skills.
Responsibilities
:
The firm is seeking a Quality Assurance Specialist. This position will assist with QA activities at the firm to ensure compliance with CLIA, CAP and FDA regulations and requirements.
Responsible for maintaining, updating and versioning of policies and protocols. Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate. Review IT change control documents including risk analysis, IQ, OQ, URS and other software validation documents. Provide constructive feedback on validation plans to software development teams. Demonstrate strong proficiency in the application of the Corrective And Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources Manage employee training files Assist in development and management of the firm's quality management system.
Required
Skills :
Bachelor's degree with at least 5 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, at least 2 of which should include direct QA experience. Must have strong regulatory compliance knowledge including GLP and GCP Must have experience writing and/or reviewing clinical software validation documents Able to assist with external audits of vendors and subcontractors Must be detail oriented with excellent prioritization and organizational skills Superior analytical and problem solving skills Must be able to deliver results on schedule in a fast-paced, dynamic environment
Preferred
Skills :
Experience in the clinical or diagnostics industry strongly desired Experience working in an environment where custom and COTS (customized of the shelf) software needs to be validated
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in
employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionOther IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at Software Guidance & Assistance, Inc. (SGA, Inc.) by 2x Get notified about new Quality Assurance Specialist jobs in
Boston, MA . Boston, MA $75,000.00-$95,000.00 1 month ago QA Tester For Free To Play Casual Mobile Game Boston, MA $85,000.00-$95,000.00 2 weeks ago Post Closing/HMDA Quality Assurance Specialist - Hybrid Eligible Cambridge, MA $132,000.00-$165,000.00 3 days ago Burlington, MA $132,000.00-$165,000.00 2 days ago Payment Integrity: Reimbursement Policy Quality Assurance (QA) Analyst Marlborough, MA $130,000.00-$155,000.00 2 weeks ago Associate Director/Director, Quality Assurance OperationsSenior Manager/Associate Director, CMC Quality AssuranceQuality Control Aerospace Manufacturing (Multiple shifts)Quality Assurance Contact Center SpecialistQuality Assurance Specialist, Cellular Therapy 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
Quality Assurance Specialist
for a
contract
assignment with one of our premier BioTech services clients in
Boston, MA .
Learn more about the general tasks related to this opportunity below, as well as required skills.
Responsibilities
:
The firm is seeking a Quality Assurance Specialist. This position will assist with QA activities at the firm to ensure compliance with CLIA, CAP and FDA regulations and requirements.
Responsible for maintaining, updating and versioning of policies and protocols. Ensure that record keeping under FDA/GLP requirements are attributable, legible, contemporaneous, original and above all, accurate. Review IT change control documents including risk analysis, IQ, OQ, URS and other software validation documents. Provide constructive feedback on validation plans to software development teams. Demonstrate strong proficiency in the application of the Corrective And Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources Manage employee training files Assist in development and management of the firm's quality management system.
Required
Skills :
Bachelor's degree with at least 5 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, at least 2 of which should include direct QA experience. Must have strong regulatory compliance knowledge including GLP and GCP Must have experience writing and/or reviewing clinical software validation documents Able to assist with external audits of vendors and subcontractors Must be detail oriented with excellent prioritization and organizational skills Superior analytical and problem solving skills Must be able to deliver results on schedule in a fast-paced, dynamic environment
Preferred
Skills :
Experience in the clinical or diagnostics industry strongly desired Experience working in an environment where custom and COTS (customized of the shelf) software needs to be validated
SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in
employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionOther IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at Software Guidance & Assistance, Inc. (SGA, Inc.) by 2x Get notified about new Quality Assurance Specialist jobs in
Boston, MA . Boston, MA $75,000.00-$95,000.00 1 month ago QA Tester For Free To Play Casual Mobile Game Boston, MA $85,000.00-$95,000.00 2 weeks ago Post Closing/HMDA Quality Assurance Specialist - Hybrid Eligible Cambridge, MA $132,000.00-$165,000.00 3 days ago Burlington, MA $132,000.00-$165,000.00 2 days ago Payment Integrity: Reimbursement Policy Quality Assurance (QA) Analyst Marlborough, MA $130,000.00-$155,000.00 2 weeks ago Associate Director/Director, Quality Assurance OperationsSenior Manager/Associate Director, CMC Quality AssuranceQuality Control Aerospace Manufacturing (Multiple shifts)Quality Assurance Contact Center SpecialistQuality Assurance Specialist, Cellular Therapy 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