Sharp Sterile Manufacturing · 1 day ago
QA Compliance Specialist I
Lee, MA, US
Full-time
Onsite
Entry Level
$64K/yr - $78K/yr
1+ years expSharp Sterile Manufacturing is seeking a QA Compliance Specialist I to assist with compliance and quality activities. The role involves implementing cGMP and regulatory requirements while maintaining and improving the Quality Culture at BSM.
BiopharmaBiotechnologyHealth CareLife Science
Responsibilities
Provide indirect oversight of cGMP operations at BSM
Work collaboratively within BSM’s Quality Management System
Author, review and approve documentation required to comply with FDA regulations, EU regulations and other regulatory agencies as applicable
Author, review and approve change controls, deviations, CAPAs, work orders, and other GMP documents (will be the primary owner of the systems)
Perform/assist in internal audits and regular walkthrough visits to the manufacturing areas and author, review and approves associated reports
Work collaboratively with other departments in order to accomplish project goals
Assist in the execution of the Pest Control program
Well-organized and proficient at reviewing and editing documentation
Ability to maintain attention to detail while executing multiple tasks
Ability to manage timelines to meet department goals
Maintain control and confidentiality of documents and information
Other duties as assigned by Manager
Exhibit a quality mindset
Conduct business in a responsible manner that complies with all state, OSHA and Federal regulations
Develop detailed and comprehensive understanding of FDA, EU and other regulatory agency requirements
Qualification
Required
One (1) to three (3) years of experience working in a cGMP environment (preferably in a QA function)
Associate's Degree (relevant experience may be substituted for degree)
Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat
High attention to detail
Good writing, public speaking and presentation skills
Ability to sit for prolonged periods of time
Ability to lift up to 25lbs
Ability to stand for prolonged periods of time
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
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