Senior Quality Assurance Specialist

5 days ago

Noblesville, United States Curium Pharma Full time
{"Job Title": "Senior Quality Assurance Specialist", "Job Summary": "We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Curium Pharma. In this role, you will be responsible for ensuring the accuracy, integrity, and regulatory compliance of documents in a regulated environment. Your expertise will be crucial in providing QA oversight to production on the floor, batch release, and Quality Events.

Responsibilities:

* Review and edit documents for accuracy, completeness, and consistency.
* Perform QA on the Floor function.
* 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, and approve 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.

Requirements:

* Bachelor Degree in Science or related field required.
* Five 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.

Working Conditions:

* Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
* Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
* Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
* Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
* May be required to sit or stand for long periods of 8+ hours a day while performing duties.
* Must possess good hand-eye coordination; close attention to detail is required.
* Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable, and toxic material, dust, dirt, odors, and irritants.
* Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
* Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.

Disclaimer:

* The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.
* They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

Equal Opportunity Employer:

* Curium is an equal opportunity employer and believes everyone deserves respect, dignity, and equality.
* All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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