2 QA Compliance Specialist I Jobs in Lee, MA

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QA Compliance Specialist I

Berkshire Sterile Manufacturing

Lee, MA | Full Time

$63k-78k (estimate)

11 Months Ago

QA Shop Floor Specialist I

Berkshire Sterile Manufacturing

Lee, MA | Full Time

$73k-89k (estimate)

11 Months Ago

QA Compliance Specialist I

$63k-78k (estimate)

Full Time | Pharmaceutical 11 Months Ago

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Berkshire Sterile Manufacturing is Hiring a QA Compliance Specialist I Near Lee, MA

Position Summary	The QA Compliance Specialist I is a quality professional who assists with compliance and quality activities at BSM. The QA Compliance Specialist assists with implementing cGMP and regulatory requirements at BSM. The QA Compliance Specialist is responsible for maintaining and improving the Quality Culture at BSM.
Duties and 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
Regulatory Responsibilities	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
Supervisory Responsibilities	N/A
Experience	One (1) to three (3) years of experience working in a cGMP environment (preferably in a QA function)
Education	Associate’s Degree (relevant experience may be substituted for degree)
Knowledge, Skills & Abilities	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
Physical Requirements	Ability to sit for prolonged periods of time Ability to lift up to 25lbs Ability to stand for prolonged periods of time

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$63k-78k (estimate)

POST DATE

05/09/2023

EXPIRATION DATE

05/10/2024

WEBSITE

berkshiresterilemanufacturing.com

HEADQUARTERS

LEE, MA

SIZE

100 - 200

FOUNDED

2014

TYPE

Private

CEO

SHAWN KINNEY

REVENUE

$10M - $50M

INDUSTRY

Pharmaceutical

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About Berkshire Sterile Manufacturing

BSM is a bio-pharmaceutical company that develops and manufactures sterile drug products for clinical applications.

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The job skills required for QA Compliance Specialist I include Microsoft Office, Problem Solving, Written Communication, Attention to Detail, Integrity, Quality Assurance, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Compliance Specialist I. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Compliance Specialist I. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for QA Compliance Specialist I positions, which can be used as a reference in future career path planning. As a QA Compliance Specialist I, it can be promoted into senior positions as a Compliance Specialist III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Compliance Specialist I. You can explore the career advancement for a QA Compliance Specialist I below and select your interested title to get hiring information.