Quality Associate I, Receiving & Inspection,

About the role

Quality Associate performs daily quality review of raw material documentation to ensure that materials being received are produced in accordance to Company methodology, procedures, and standards. Quality Associate completes Change Control, Supplier Quality, and Nonconformance and Corrective Action Preventive Action (CAPA) quality records related to Receiving & Inspection. Quality Associate is SME for Receiving & Inspection procedures and manages projects. The candidate must not be allergic to Penicillin or Cephalosporin drugs.

What You'll Be Doing

• Reviews and approves documentation for API (Active Pharmaceutical Ingredients), Excipients, Chemicals, Laminated Rollstock, Printed Direction Inserts, Labels, and Cartons
• Provides Receiving and Inspection review support for materials purchased by Takeda
• Manages raw material tracking log and scheduling work for R&I technicians
• Manages RLDD Stability schedule and sends out Stability notices
• Strong computer/software literacy, preferred experience with material inventory management systems
• Creates reassay and expiration report on a monthly basis
• Completes GME and Labvantage setups for materials
• Supplier Quality (SQ) responsibilities to include SCAR (Supplier Corrective Action Request) writing and review; Reduced testing of materials - new and periodic review; SQ approval of raw material part records; and Risk Action and Mitigation (RAM) review for Round Lake Drug Delivery
• Owns and manages Change Control records
• Performs investigations for R&I nonconformances and owns R&I related CAPAs
• Performs R&I procedure and training code revisions in document system
• Completes Certification of Documentation Review (CDR) process for raw materials to implement them in the plant systems
• Validation and testing of computerized systems, to include writing and executing a protocol
• Submit and manage purchase orders in Coupa system
• Manages quotes and sends samples to external testing labs
• Complete and manage R&I Preventive Maintenance (PM) records in the Maximo system
• Attends various Tier and Cross-Functional meetings as the R&I representative
• Secondary responsibilities to support production, as needed
• Will work in both Drug Delivery and Penicillin facilities as needed

Qualifications

• Associates Degree and one to three years of relevant experience required OR Bachelor's degree and experience with a medical device/pharma or other similarly regulated industry preferred
• Good writing and verbal communication skills, and problem-solving skills are required
• Ability to work in a team environment and make independent decisions based on procedural and regulatory requirements
• Complete understanding of cGMPs and GDP procedures
• 20/30 vision in at least one eye with or without corrective lenses
• The candidate must be able to work flexible hours in a dynamic environment with minimal direct supervision

Pay

The estimated base salary for this position is $68,000 - $93,500 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits