Labeling Specialist

Education – associates degree

entry level

Years of exp someone out of college is ok

Need to know standard regulations and medical industry

Duties:

• Create/Update, issue and distribute product artwork of current versions of QuarkXPress, CS5 including (Adobe Illustrator, Photoshop, InDesign etc.).
• Support routing and approval processes as required.
• Attend product launch meetings as required.
• Ensure artwork schedule adherence and provide communication regarding priorities.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Assess proposed artwork packages and take appropriate actions to create, update to currently indicated standards, proofing, pre-flight, and communicate with production sites to ensure electronic artwork for AMO labeling/packaging components meets AMO graphic standards and release requirements. And other activities as define by management.
• Participate in project team development meetings and with third party design artwork suppliers to support the initiation of appropriate artwork meeting requirements to minimize rework and delays.
• Responsible to manage computer generated labeling formats and to ensure production validation activities are addressed before authorizing release for production use.
• Monitor actions and escalate issues to department and project team management regarding artwork releases to meet project plan deadlines.
• Requires a minimum of 2 years Production graphics experience in a quality or operational function, preferably in a medical device environment or similarly regulated environment.
• Must have capacity for attention to detail with the ability to recognize errors in spelling, punctuation, and grammar.
• Must be able to work independently as well as within a team.
• Good oral and written communication and strong organizational skills necessary.
• Able to manage multiple tasks and prioritize accordingly to meet challenging deadlines.
• Must exhibit flexibility in meeting constantly changing demands.
• Must have good customer focus with ability to influence internal and external groups.
• Must have experience with graphics programs, word processing, and database/spreadsheet programs and bar-code applications as currently utilized at AMO on both the Macintosh and PC platforms.
• Prior labeling development and proofreading experience is helpful.
• This is not a creative design.
• Production artwork tech, not a lot of photo shop, design is aligning things blocks of texts together, symbols on a label cached on ISO and FDA regulations. Serious of applications, adobe creative cloud.
• No photo shop, building IP they are creating, also use Microsoft word, adobe acrobat and a variable label design, called easy label, other applications bartender.
• Will follow all regulations.
• Not a lot of technical writing just copying and formatting from work document and pull into InDesign, some data base population, a lot of data input.

Reminder

• This is not a creative design position.
• Label creation includes placing data and symbols onto a label template and transferring information into a database.
• Must have attention to detail.
• A very specific process must be followed to align with ISO and FDA regulations.
• Instructions for use creation includes working with styles and formatting in Adobe InDesign and Microsoft word.
• Must have the ability to learn various software programs quickly.
• Applicant with in a quality background is desired.
• Entry level.
• Associates Degree or equivalent experience as a label designer in the Medical Device industry.

Job Type: Contract

Pay: $21.00 - $23.00 per hour

Expected hours: 40 per week

Benefits:

• Flexible schedule
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Associate (Preferred)

Experience:

• Prior labeling development and proofreading: 3 years (Preferred)
• ISO and FDA regulations.: 2 years (Preferred)
• pharma or healthcare or medical device industry: 2 years (Preferred)

Ability to Commute:

• Temecula, CA 92590 (Preferred)

Work Location: In person

Salary : $21 - $23