Sharp Sterile Manufacturing · 15 hours ago
QA Compliance Specialist
Lee, MA, US
Full-time
Onsite
Entry Level
$64K/yr - $78K/yr
1+ years expSharp Sterile Manufacturing is dedicated to maintaining high standards in quality compliance, and they are seeking a QA Compliance Specialist to enhance their quality culture. The role involves supporting compliance initiatives, authoring documentation for regulatory requirements, conducting audits, and collaborating with various departments to meet compliance objectives.
BiopharmaBiotechnologyHealth CareLife Science
Responsibilities
Maintain and enhance the company’s quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements
Operate within and support the execution of BSM’s Quality Management System
Author, review, and approve documentation required for compliance with FDA, EU, and other applicable regulatory agency requirements
Serve as the primary owner of quality systems, including the review and approval of change controls, deviations, Corrective and Preventive Actions (CAPAs), work orders, and other GMP-related documentation
Assist with and conduct internal audits and routine walkthrough inspections of manufacturing areas; author, review, and approve associated audit reports
Collaborate with cross-functional departments to meet project and compliance objectives
Support the execution of the facility’s pest control program
Demonstrate a strong quality mindset in all aspects of work
Conduct business in compliance with all relevant state, federal, and OSHA regulations
Maintain a comprehensive understanding of FDA, EU, and other applicable regulatory requirements
Qualification
Required
Master's degree in Regulatory Affairs or related field (or foreign degree equivalent)
At least 1 year of quality assurance experience in a cGMP environment
At least 1 year of experience reviewing and editing GMP documentation, including change controls, deviations, CAPAs, and SOPs
At least 1 year of experience supporting internal audits and preparing documentation for FDA or other regulatory inspections
At least 1 year of experience performing root cause analysis and developing corrective and preventive actions (CAPAs)
At least 1 year of experience using electronic quality management systems (MasterControl, Veeva, or similar)
At least 1 year of experience using Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat
At least 1 year of experience with compliance and data integrity best practices
At least 1 year of experience managing various projects and timelines to meet department goals
Company
Sharp Sterile Manufacturing
Sharp Sterile (formerly Berkshire Sterile Manufacturing) provides the safest sterile drug products for clinical use and small scale requirements through the use of modern technology, 100% isolator-based filling lines, and a skilled staff.
201-500 employees
H1B Sponsorship
Sharp Sterile Manufacturing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (7)
2023 (6)
2022 (2)
2021 (2)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$2MKey Investors
MassDevelopment
2023-10-05Acquired
2018-07-17Debt Financing· $2M
Recent News
Company data provided by crunchbase