Quality Assurance Specialist

Software Guidance & Assistance, Inc. (SGA, Inc.); Boston (MA); On-site; USD 50,000 - 55,000; Full time

Job summary

Software Guidance & Assistance, Inc. (SGA, Inc.) is looking for a Quality Assurance Specialist in Boston. In this role, you will ensure compliance with regulatory standards while participating in quality assurance activities. Candidates should have substantial experience in the pharmaceutical or biotech sectors, with a strong foundation in QA practices and regulatory requirements.

Qualifications

• 5 years of experience in pharmaceutical or biotech industries with QA focus.
• Strong regulatory compliance knowledge (GLP, GCP).
• Experience with software validation documents.

Responsibilities

• Assist with QA activities to ensure compliance with regulations.
• Maintain and update policies and protocols.
• Review IT change control documents.

Skills

Regulatory compliance

Analytical skills

Problem solving

Attention to detail

Organizational skills

Education

Bachelor's degree

Job description

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.

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 level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  IT Services and IT Consulting

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