SUMMARY
The Visual Inspector Lead is responsible for visually inspecting filled products according to Wells Pharma’s quality sampling plan to ensure no visible defects to product or packaging and no visible particulates in the filled product containers.
The Visual Inspector Lead is responsible for ensuring that the inspectors are trained and requalified per the SOP and regulatory guidelines.
This position will work under the direction of the Quality Assurance Management
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Perform 100% inspection of filled but unlabeled products for functional defects, particulates, and cosmetic defects under controlled inspection conditions.
- Units must be inspected prior to shipment to the customer.
- Work independently following documented procedures in a current Good Manufacturing Practices (cGMP) environment optimized to limit distractions to ensure appropriate attention to inspection details.
- Become the Subject Matter Expert (SME) for automation as it relates to visual inspection
- Create and or revise standard operating procedures for visual inspection.
- Collaborate with the team and establish process improvements to reduce waste of resources
- Perform manual and automated visual inspection processes.
- Complete paperwork documenting inspection activities accurately and timely according to standard operating procedures and current Good Documentation Practices guidelines.
- Maintain a clean and organized environment while ensure product is inspected in a timely manner.
- Perform and document additional quality checks on products, as needed.
- Perform additional duties as assigned by Quality management.
KNOWLEDGE, SKILLS, & ABILITIES
- Knowledge of cGMP regulations as it pertains to 21 CFR 210, 211 and 503B regulated environments.
- Strong verbal, written communication skills and computer skills are required.
- Must be goal-oriented, quality-conscientious, and customer-focused.
- Effective oral and written communication skills.
- Ability to read, understand, and follow work instructions for automation
Page 2 of 2
- Ability to work independently and cooperatively on a team.
- Knowledgeable of electronic inventory systems.
CORE VALUES
- The Visual Inspector Lead is expected to operate within the framework of Wells Pharma’s Core Values.
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Exercise respect and honesty.
- Readily adapt to the culture that is patient focused and dedicated to making a difference.
COMPANY SUCCESS
- Go the extra mile to make things happen and be committed in all aspects.
- Embrace change with enthusiasm, giving positive criticism, respectfully.
EDUCATION & EXPERIENCE
- H.S. Diploma (or GED) with 3- 5 years of experience
- Able to work independently for an extended period.
- Able to work under bright light for 8 hours per day.
- Must have 20/20 unaided or corrected vision and must not be colorblind.
- Experience in a cGMP environment recommended, but not a requirement.
- Must be detail oriented
- Ability to read, understand, and follow detailed written procedures (Standard Operating Procedures).
- Must be self-driven and able to internally motivate self.
- Must have good written and oral communication skills.
- Must be able to lift and carry up to 25 lbs.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- Day shift
- Monday to Friday
Work setting:
- In-person
Application Question(s):
- Do you have 20/20 unaided or corrected vision? Reuired
- Are you colorblind? Must NOT be for this position.
- Are you experienced in a cGMP environment? Recommended, but not a requirement.
- Are you able to read, understand, and follow detailed written procedures (Standard Operating Procedures)? Required
Education:
- High school or equivalent (Required)
Work Location: In person