Job description

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

Title: QS (Quality Systems) Specialist II

Focus: Internal and External Audit Oversight

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.

Summary

Nexus Pharmaceuticals, Inc. is seeking a detail-oriented Quality Assurance Specialist II to implement company and regulatory quality standards to support the Quality Management System (QMS). This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills. Must have good conflict resolution and negotiation skills along with independent decision-making capabilities to think conceptually and understand impact of decisions. Qualified candidate will be hired at the appropriate level commensurate with education and years of required relevant experience.

Responsibilities:

• Lead process improvement initiative to enhance Nexus’ supplier control program
• Manage supplier control program files, reports, and records on electronic drive system integration into MasterControl
• Review and track trends of monthly and annual reports sent by Lambda (inquiries, complaints, ICSRs, PADERs, risk evaluation, and mitigation strategy reports)
• Write and/or review investigation, reporting, and responses to complaint inquiries
• Manage SCAR program to investigate issues/problems/defects associated with non-compliance to a process/procedure with a supplier
• Independently manage, conduct, and report assigned investigator site, vendor, and internal process/function audits according to internal SOPs and regulations
• Provide audit reports to system/process owners and management
• Review and approve audit reports, audit responses, and supplier investigations, and evaluate adequacy of corrective and/or preventative actions and effectiveness reviews
• Assist in cGMP compliance related activities including any systems and/or tools, as needed
• Support supplier quality program activities including development and reporting of KPIs, new supplier qualification, drafting of quality agreements, supplier questionnaires, and audit agendas, providing system administration for management of suppliers, SCAR initiation/review/approval, and maintenance of approved supplier lists
• Schedule audits internally and with consulting firms
• Manage internal and external audit schedules
• Train personnel in support of auditor qualifications
• Assist in implementing and maintaining a comprehensive risk-based GMP supplier quality, internal/external audit, and complaint management system program
• Provide cGMP compliance SME support during global regulatory agency inspections and other ad-hoc audits as needed
• Participate in inspection readiness activities including inspections by regulatory authorities (FDA/DEA)
• Identify and assist in developing standard operating procedures (SOPs) and systems needed to comply with regulatory requirements
• Support the document and change management program; work cross functionally to bring changes to closure and managing effectiveness
• Perform quality reviews of documentation in area of responsibilities as needed
• Perform tasks/deviations/investigations/protocols/CAPAs of moderate and high complexity; work closely with other members of the organization during investigations to determine root cause and potential preventive/corrective actions
• Responsible for the timely closure of investigations
• Support document control system in writing, reviewing, and issuing controlled documents
• Model 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
• Required to exercise good judgement as errors may cause moderately serious delays, confusion, and could affect company reputation and/or customer relations

Desired Characteristics:

• Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
• Computer literate, ability to work with MS Office and software programs related to the position
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
• Experience working with cross-functional groups such as planning, manufacturing, packaging, and distribution to ensure proper priorities are set and necessary activities are planned to meet these goals
• Ability to read, understand and follow instructions written in English in SOPs, batch records, cGMPs, etc.
• Multi-tasking and prioritization skills
• Must be able to work independently
• Strong organizational skills

Education or experience:

• 4-year bachelor’s degree in science-related discipline
• 3+ years’ experience within heavily regulated manufacturing facility, pharmaceuticals preferred
• Knowledge of Microsoft Office Suite Programs required
• ASQ Certified Quality Auditor (CQA) preferred

Travel Requirements:

• 15-35% travel required for this role

Physical Requirements:

• Prolonged periods of sitting at a desk, working on a computer, and talking on the phone
• Must be able to lift up to 15 pounds at times

Level of Proficiency:

Must be able to work independently

Strong organizational skills

Ability to set long-term goals and objectives

DISCLAIMER: The list under Role Responsibilities are 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.

Job Type: Full-time

Pay: From $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 3 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Work Location: In person

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