Mqa Inspector Ii

Nexus employees earn 4 weeks’ vacation per year, and our benefits start on day 1!

Title: MQA (Manufacturing Quality Assurance) Inspector II

Full Time

Location: Pleasant Prairie, WI

Our Company

Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.

Responsibilities:

• Manage stopper qualification program
• Support the warehouse in material receipt discrepancies by performing visual assessments and associated documentation
• Perform physical (dimensional) inspection of incoming vials, stoppers and seals according to AQL sampling plans
• Perform finished drug product inspections (including manual, semi-automated and automated inspection scenarios)
• Perform inspection of media fill vials at appropriate intervals to support qualification of the aseptic filling process
• Approve packaging areas for production use
• Audit packaging and inspection processes to ensure cGMP compliance
• Assists Operations and Supply Chain personnel in updating inventory levels as a result of sampling, testing, and/or deviations
• Assign QA status (Release/Reject) to materials and finished product.
• Perform investigation of product nonconformances, conduct root cause analysis in accordance with internal procedures
• Assist in product recalls
• Identify and respond to instances of packaging deviations and discrepancies; assess risk to product and provide recommendations to management for resolution
• Generate and issue batch records for packaging operations
• Review packaging records for batches to assure compliance with cGMP before being released for further processing or commercial release
• Review logbooks for accuracy, completeness, compliance to company standard operating procedures and regulatory guidelines/regulations
• Identify improvements/new procedures/ compliance gaps based on applicable regulations
• Manage quality inspection documents to ensure continued regulatory and procedural compliance
• Participate in change control process as necessary to maintain document audit readiness
• Manage and maintain all component specification generation and revision
• Manage and maintain the retain and retention program according to internal procedures and Federal Regulations
• Performs tasks/deviations/investigations/protocols/CAPAs of moderate and high complexity; works closely with other members of the organization during investigations to determine root cause and potential preventative/corrective actions. Responsible the timely closure of investigations
• Responsible for the timely closure of investigations and other quality records
• Interact with suppliers and vendors as needed to ensure continued material quality and/or assist with non-conforming material
• Perform internal audits according to schedule to identify areas of concern and/or process improvements based on current federal regulations.
• Participates in inspection readiness activities and assists in inspections by regulatory authorities (FDA/DEA)
• Models effective and constructive communication behaviors and interactions with technical departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g., interpersonal) skills
• Act as Subject Matter Expert for Quality inspection and release process
• Create GMP component specifications
• Assist in product recalls
• Other duties as assigned

Skills and Abilities:

• Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
• Must be able to work independently
• Strong organizational skills
• Ability to set long-term goals and objectives

Education and Experience:

• 4-year bachelor’s degree in science-related strongly preferred. (Additional GMP Quality Experience may be accepted in lieu of degree)
• 3+ years of relevant experience. Pharmaceutical preferred
• Knowledge of Microsoft Office Suite Programs required
• Familiarity with digital QMS systems, MasterControl preferred

Travel Requirements:

• 5 – 15% travel required for this role (domestic or international)

Physical Requirements:

• Lifting requirements less than 50 pounds
• 50% of day in Manufacturing / 50% in office
• Office, Manufacturing, and Laboratory Environment
• Occasional use of ladder
• May be qualified to use warehouse equipment
• Must be able to pass visual acuity testing administered as a condition of employment and annually thereafter confirming 20/20 corrected vision

Level of Proficiency:

• Must be able to work independently
• Strong organizational skills

DISCLAIMER: The list under Role Responsibilities is not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.

EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.