QA Specialist
Beacon Hill Staffing Group, LLC

Summary of Position

The Quality Assurance Specialist position is responsible for product oversight, material release, technical writing and document creation and is focused on ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. This position will provide QA oversight to production on the floor, batch release and Quality Events. This position reports to the Senior Director of Quality.

Essential Functions

Review and edit documents for accuracy, completeness, and consistency.

Perform QA on the Floor function.

Gown into a grade C and D environment.

Monitor aseptic operations for Quality Assurance.

Review batch record completeness for accuracy and compliance.

Review and release incoming materials for accuracy and compliance.

Manage and prioritize projects in an organized and structured manner. Create, review, and approve Quality policies and procedures.

Write, review, approve and monitor Quality Events (Deviation, Change Control, CAPA, etc).

Support regulatory and client audits.

Conducts internal audits of the QMS and sub systems.

Analyze data to identify areas for improvement in the quality system.

Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU,HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

Bachelor Degree in Science or related field required.

3 or more years of relevant experience in a Pharmaceutical or Medical Device Quality Systems/Quality Assurance

Knowledge of tools, concepts and methodologies of Quality.

Auditing experience, along with deviation and lot release support.

Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of Computer Systems

Working knowledge of cGMP guidelines.

Proficient in use of Microsoft suite of products.

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com .

We look forward to working with you!

Beacon Hill. Employing the Future™