Visual Inspection & Labeling Coordinator

Visual Inspection, Labeling and Packaging (VILP) Coordinator

This description is intended to be illustrative of the major duties to be performed.

This position reports directly to the VILP Manager, the role is responsible for general support of inspection, label, and packaging activities. The VILP coordinator is responsible for coordinating and possibly expediting the flow of paperwork and materials within the VILP department, and between support departments in order to meet the production and product release schedules. The coordinator ensures that all materials and supplies are provided in a timely manner in order to maintain the appropriate production levels and ensure customer commitments are met.

Essential Functions:

• Provide administrative and office support for the VILP department, VILP activities with other support groups to receive components, QC results, etc.
• Collaborate with VILP Supervisors to ensure completion of Visual Inspection, Label, and Packaging of products to meet scheduled release dates.
• Control the incoming and outgoing documentation process.
• Perform review and reconciliation of all batch related materials in a timely manner.
• Review batch records and facilitate Good Documentation Practice errors for corrections.
• Assist in drafting event initiation forms, investigation, and resolution of deviations.
• Maintains inventory of supplies and parts needed to complete VILP activities, including laundered gowns and plant uniforms.
• Prepare and coordinate batch reject units for transfer and destruction.
• Ensures compliance with company policies, FDA regulations, GMP's, and all safety standards.
• Collect department metrics.
• Other duties as assigned.

Supervisory Responsibilities:

• Assist the Shift Supervisor in the day to day supervision of the visual inspection, labeling and packaging shift.

Experience and Necessary Skills:

• Bachelor's degree in related field or equivalent experience required
• 3+ years preferred, 6 months required of experience involving inventory control, batch record handling/reviewing, and knowledge of Good Documentation Practices.
• Able to lift up to 50 lbs. and stand for extended periods when required.
• Knowledge of cGMP guidelines/standards.
• Demonstrated written and oral communications skills including strong presentation skills.
• Excellent organizational skills and results oriented.
• Works well under pressure and can prioritize workloads.
• Works well in a team environment.
• Possesses a strong attention to detail.
• Excellent Microsoft Office skills, including Outlook, Word and Excel, are required.

Physical Requirements:

• Ability to stand or sit for extended periods of time.
• Ability to lift, push and pull up to 50 pounds periodically.
• Ability to maintain a gowning qualification, for ISO 7 area.

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program

Shift: Monday-Friday, 3:30pm-12:00am

Pay: Base Hourly Rate + $2/hour differential while working 2nd shift

Timeline: We will be accepting applications on an ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.