Job Description – Quality Assurance Technician

Rockwell Medical

Job Responsibilities:

1.Document Auditing

Responsible for auditing of device history quality records related to approval and release of raw materials (chemicals), incoming label shipments, sub-assembly lots and finished goods lots.

2.Document Control

Responsible for site document control processes, including:

•routing and review of new/revised documents;

•revision control of distributed procedures, forms and work instructions;

•Delivery of signature pages (hard copy and/or electronic) to designated personnel to support document control process.

•Supports writing of new and revised documents, as required.

3.Returned/Damaged Goods Process

Inspects and determines disposition of returned goods. Facilitate the repackaging/relabeling of damaged goods.

4.Rework Process

Supports documentation of instructions for rework and re-inspection of potentially nonconforming materials. Provides quality assurance oversight of rework activities as required and assure inspection of reworked materials is performed per original manufacturing specifications.

5.Internal Audits

Participate in site internal audit program to compliance of site activities to 21 CFR 820 Good Manufacturing Practices.

6.Training

Support training activities and maintenance of training documentation, as requested.

Minimum requirements:

•Minimum Associates Degree preferred with 1 - 2 years experience in a regulated industry, preferably FDA.

•Excellent attention to detail and ability to apply procedural requirements to review of records.

•Excellent verbal and written communication skills.

•Ability to read, interpret technical documents and regulations.

•Willing to work shifts, including weekends/overtime as required.

•Must be able to pass background/drug check.

Expectations/Other skills for this position:

•Good work history, positive attitude, good attendance record and proven work ethic.

•Strictly comply with Standard Operating Procedures and GMP practices and guidelines.

•Ability to work independently in a self-directed, productive manner

•Able to communicate and effectively work with associates at all levels of the organization

•Manage time and resources effectively through good organizational skills and positive problem solving skills.

•Commitment to continuous improvement.

•Physical demands: ability to sit at desk and work on a computer, reaching on shelves to transfer binders, lifting/moving archive boxes (no heavier than 20 lbs).

EEO Statement

• Rockwell Medical provides equal employment opportunities to all employees and applicants for employment and does not discriminate based on an individual's race, color, creed, national origin, religion, disability status, age, sex, genetics, protected veteran status, sexual orientation, marital status, gender identity or expression, or any other characteristic protected by federal, state or local laws.

• This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

• Please note that this job description is not intended to be an exhaustive listing of all activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Minimum requirements:

•Minimum Associates Degree preferred with 1 - 2 years experience in a regulated industry, preferably FDA.

•Excellent attention to detail and ability to apply procedural requirements to review of records.

•Excellent verbal and written communication skills.

•Ability to read, interpret technical documents and regulations.

•Willing to work shifts, including weekends/overtime as required.

•Must be able to pass background/drug check.