Job description

Job Description:

How will you make an impact?

• The Quality Assurance Specialist role is a key member of the Quality Assurance team that supports site operations such as material/components/label receipt, in process control checks and oversight of operational execution, cleaning/clearance, etc.
• Partners internally to identify and resolve issues that are identified during site material handling and operational activities. Supports the site’s execution of the principles of current Good Manufacturing Practices (cGMP).

What will you do?

• Take appropriate actions using Quality Systems, Quality management and oversight (e.g. during review/approval) to ensure adequate controls are in place to assure a high level of product quality and safety.
• Supports the cGMP document (SOPs, Forms, Logbooks, Batch Records, etc.) control processes used during operational activities.
• Perform packaging startup checks, inprocess Quality checks and accountability.
• Perform AQL sampling and inspection activities during operation activities.
• Ensures Label Document Compliance through examination of Label Specifications, Master Label Proofs, Randomizations, and Links Reports.
• Review and approval of printed labels, printed packaging components and Fisher supplied packaging components.
• Provide assistance and mentorship on quality issues or documentation for Operations. Identify deviations and raise issues to Quality Assurance Representative and/or Quality Manager.
• Performs all job responsibilities with respect, integrity and intensity keeping a focus on Quality and Safety for employees. Accepts opportunities and other activities requested by leadership to support business needs.

How will you get here?

• High School Diploma or Equivalent

Experience Required

• Two years of production or quality experience. Preferably in a GxP manufacturing or packaging industry.

Knowledge, Skills, Abilities

• Proven history of participating on cross functional teams as well as the ability to build interpersonal relationships with peers and other functional areas.
• Familiarity with cGMPs and Quality Management System tools/applications (e.g. TrackWise, Documentum, etc.) and basic digital literacy.
• Ability to multitask and effectively prioritize activities for self and team.
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and operational locations; ability to stand, sit or walk extensively. Some manipulation (lift, carry, move) of light to medium weights of 525 pounds may be necessary.
• Hand and finger dexterity, including visual acuity to use a keyboard, computer monitor, and read materials for prolonged periods of time.
• Minimum vision requirements for the role include Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or less), color vision and ability to adjust focus.

Job Types: Full-time, Contract

Pay: $23.00 per hour

Schedule:

• 10 hour shift
• 4x10

Ability to commute/relocate:

• Indianapolis, IN 46221: Reliably commute or planning to relocate before starting work (Required)

Experience:

• production or quality: 2 years (Preferred)
• Quality Management System tools: 1 year (Preferred)
• CGMP: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location

colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, colinoncars.com is the ideal place to find your next job.