QA Compliance Specialist I

Job Description

Position SummaryThe 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

Full-time