On-Site QA Supervisor

Torrey Holistics; Waunakee (WI); On-site; USD 50,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

401k Plan

Job summary

Scientific Protein Laboratories (SPL) is seeking an On-Site QA Supervisor in Waunakee, WI. The role oversees QA staff, conducts on-site inspections, releases materials and products, and drives continuous improvement of cGMP systems in accordance with FDA/ICH/USDA guidelines.

The ideal candidate has 5+ years of QA experience in pharma, an Associate degree (Bachelor’s preferred), and strong documentation and auditing skills. This is a first shift, full-time position with excellent benefits.

Qualifications

• Bachelor's degree or higher preferred; Associate degree required with 5+ years QA experience in pharma.

Responsibilities

• Oversee on-site QA staff and perform inspections of manufacturing/testing areas.
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Skills

GMP knowledge

QA supervision

Batch record review

CAPA management

Auditing

eQMS

Regulatory compliance

Root cause analysis

Documentation

Education

Associate degree

Bachelor’s degree or higher

Tools

MasterControl

eQMS

Job description

**JOB SUMMARY**Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as an On-Site QA Supervisor. This is a 1st shift position.This position is responsible for supervision of the sites on-site Quality Assurance responsibilities including but not limited to on-site inspection, batch record review and raw material inspection/release. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate product, release assessment of finished product; review of batch records; review of investigations, deviations, change controls and CAPAs; pest control; raw material inspections/release. The supervisor is responsible for personnel activities such as: reviews, workload management and coordination of training.**Shift:** 1st Shift**Responsibilities include:**Oversee the functions of the on-site QA staff to include but are not limited to on-site inspection of manufacturing/testing areas, sampling and release of raw materials, pest control, review of manufacturing and packaging batch records.Organize the establishment/maintenance of relevant procedures/documents.Assists all departments in the identification and evaluation of facility events. Assures proper documentation is initiated to capture the event.Determine disposition of packaging materials, in-process materials and products on the basis of approved specifications.Participates in the preparation of Annual Product Review documentation for all SPL Marketed Products.Provide appropriate data and QA support for SPL regulatory functions.Coordinates/reviews deviations, investigations, change controls and CAPAs.Participates in audits and addresses audit findings where necessary.Performs intermediate product release and finished product release assessments.Product shipping release.Responsible for continuous improvement of SPL cGMP Quality Systems to support on-site QA in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.Compiles and communicates metrics associated with on-site QA to management as required.**Job Requirements and Qualifications:****Required:**Associate degree and 5+ years of relevant experience**Preferred:**Bachelor’s degree or above10+ years of relevant experience**WHY JOIN SPL?**Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!You should be proficient in:Good Manufacturing Practices (GMP)batch record reviewchange controldeviationseQMSQAQuality AssuranceQuality ComplianceQuality Management Systemsraw material inspectionCAPA'sMachines & technologies you'll use:eQMSQuality Management SystemsMaster Control