This range is provided by Lead Candidate. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$55,000.00/yr - $70,000.00/yr
Direct message the job poster from Lead Candidate
Talent Partner | Fuelling growth for CDMOs, CROs, and Pharma Services | Pragmatic Solution Finder | MSc Psychology
About the Company
At the heart of therapeutic innovation, this organization provides flexible GMP cleanroom suites and operational support for life sciences companies focused on clinical or commercial production. Facilities include ISO 7/8-classified cleanrooms, secure IT infrastructure, and dedicated office and meeting space. Spaces are tailored to individual process and equipment needs, with services such as material and inventory management, routine cleaning, waste handling, and onsite support. The goal is to offer a reliable, compliant environment that helps teams stay focused, organized, and ready to advance their work.
About the Role
We are seeking a detail-oriented and reliable Quality Specialist I to support our clients in the life sciences. This entry-level position plays a key role in maintaining quality standards, supporting documentation review, and ensuring compliance with Good Manufacturing Practices (cGMP) and company procedures. Ideal for individuals with hands-on experience in regulated environments, strong documentation skills, or quality-related certifications.
This is a full on-site position between 2 different sites both in Boston.
Responsibilities
* Collaborate cross-functionally with Operations, Testing Services, and other departments to resolve quality issues.
* Support deviation, CAPA, and change control processes.
* Participate in internal audits, inspection readiness activities, and support external regulatory inspections as needed.
* Assist in reviewing and maintaining controlled documents (SOPs, incoming material lot files, logbooks, forms).
* Perform data entry and record review in quality systems (paper-based or electronic).
* Conduct room and equipment release under supervision.
* Assist in reviewing validation protocols for completeness and accuracy.
* Maintain accurate and up-to-date training records.
* Follow Good Documentation Practices (GDP) and contribute to a culture of compliance and continuous improvement.
Requirements
* High school diploma or GED
* At least 1 year of experience in a pharmaceutical, biotech, food, or regulated manufacturing environment
* Completion of a technical or vocational program in life sciences, chemistry, biotechnology, or manufacturing
Preferred:
* Certification in quality systems, GMP, or related area (e.g., ASQ Certified Quality Technician)
* Familiarity with FDA regulations, cGMP, or ISO quality systems
* Experience handling quality documentation and reports
* Strong attention to detail and communication skills
* Proficiency in Microsoft Office (Word, Excel)
Compensation range
$55,000-70,000
Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance, Customer Service, and Manufacturing
* Industries
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at Lead Candidate by 2x
Inferred from the description for this job
401(k)
Medical insurance
Get notified when a new job is posted.
Sign in to set job alerts for “Quality Specialist” roles.
Sr. Quality Assurance Specialist, Plant Operations
Boston, MA $75,000.00-$105,000.00 6 days ago
Sharon, MA $100,000.00-$130,000.00 1 week ago
Providence, RI $57,530.00-$78,000.00 1 week ago
Worcester County, MA $30.00-$34.00 2 days ago
Boston, MA $130,000.00-$140,000.00 3 weeks ago
Brockton, MA $70,000.00-$90,000.00 1 week ago
Waltham, MA $58,656.00-$100,500.00 1 week ago
New Bedford, MA $72,057.50-$89,995.00 2 weeks ago
North Billerica, MA $110,000.00-$130,000.00 2 weeks ago
Bedford, MA $120,000.00-$170,000.00 1 day ago
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