QA Label Specialist; Columbia, MD

Overview

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

The QA Document Control Specialist is primarily responsible for producing product labels to support manufacturing operations. This role also involves generation and maintenance of label templates used to print product labels and document change control for new or revised product labels. The position includes document control functions such as batch record printing and archival, and is critical for regulatory compliance.

• Generate and inspect complex product labelling for all products in current production, identifying minute defects on printed labels.
• Generate, print, and inspect paperwork according to established procedures and good documentation practices.
• Coordinate the printing schedule based on the production plan to ensure manufacturing operations are not halted due to lack of product labels.
• Work within the electronic document control system to create new or revise current specifications and procedures as needed.
• Assist with assigning product lot numbers and issuing and inspecting batch records for each manufacturing process.
• Scan, file, and archive quality records as needed.

• High School Diploma with 2+ years of experience required.
• Associate or bachelor's degree, preferably in a biotechnology-related field.
• At least 1 year of experience in a regulated biotechnology environment (GMP, GTP).
• 1+ year of experience performing document control functions or printing and inspecting large quantities of labels.
• 1+ year of experience in a detail-oriented inspection role (visual inspection).
• Working knowledge of Microsoft Office (Word and Excel).
• Ability to work in a fast-paced environment with a collaborative mindset.
• Ability to focus for extended periods on visual inspection.
• Physical Demands: sit for long periods; able to lift 25-40 lbs.

The anticipated base compensation range for this position is $47,500 - $71,250 USD annually. The actual base pay offered will be based on factors such as job-related knowledge/skills, experience, location, and internal equity. It is not typical to hire at the top of the range. In addition to base pay, we provide competitive bonuses and benefits, including medical, dental, and vision coverage, a 401k program, tuition reimbursement, and other wellness offerings.

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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