Operations On-Site QA Specialist

Scientific Protein Laboratories; Waunakee (WI); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, Dental and Vision on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health Savings Account

Employee Assistance Program

401(k) plan

Paid Holidays

Generous vacation

Career advancement opportunities

Job summary

Scientific Protein Laboratories (SPL) seeks an Operations On-site QA Specialist in Waunakee, WI. This role performs on-site QA tasks under supervision, learns to independently support QA functions, and participates in batch record reviews, documentation verifications, and audits to ensure cGMP compliance at our Waunakee site.

Qualifications include a science degree or 2+ years QA in regulated industry, with 2+ years writing deviations/investigations and conducting inspections; prior cGMP pharma

Qualifications

• Bachelor’s Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industry
• 2 years’ experience writing deviations and investigations
• 2 years’ conducting walk throughs using checklists
• Completing Control Document revisions
• Conducting Inspections
• Experience in cGMP in a pharma manufacturing facility

Responsibilities

• Conducts on-the-floor reviews of manufacturing and testing operations
• Performs verifications to support batch records, cleaning records, logbooks and test methods
• Assists in identification and evaluation of facility events
• Performs on-the-floor reviews of executed batch records
• Assists in establishing/maintaining procedures and documents
• Supports the document control team in issuing records as needed

Education

Bachelor’s Degree in a Scientific discipline

2+ years QA experience in a regulated industry

2 years’ experience writing deviations and investigations

2 years’ conducting walk throughs using checklists

Conducting Inspections

Experience ensuring operators adhere to safety procedures

Job description

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 Operations On-site QA Specialist.Under minimal supervision from senior team members, this position executes written procedures associated with on-site Quality Assurance responsibilities focusing on on-site inspection of manufacturing and testing operations. The Operations On-Site QA Specialist will be introduced to the on-site QA department and associated functions and responsibilities. The individual will have prior experience in a cGMP QA setting similar to the items outlined below. With guidance from management this role will be responsible for learning the process and steps required to perform all functions independently. It is the expectation that the Operations On-Site QA Specialist will quickly learn to independently provide QA support to the organization as outlined below.Work Schedule:This is a 12-hour day shift - 4 am to 4 pmWeek 1: Sunday, Wednesday and ThursdayWeek 2: Monday, Tuesday, Friday and SaturdayResponsibilities include:Conducts on the floor reviews of all manufacturing and testing operations.Performs verifications required to support manufacturing and testing documentation (including but not limited to batch records, cleaning records, logbooks, and test methods).Assists all departments in the identification and evaluation of facility events.Performs on the floor reviews of executed batch records.Assists in the organization and/or the establishment/maintenance of relevant procedures/documents.Assists in audits where necessary.Supports the document control team in issuing records as needed.Performs other duties as assigned.Job Requirements and Qualifications:This position is open to candidates with a range of relevant experience levels. Candidates meeting the minimum qualifications are encouraged to apply. Final job level and compensation will be determined based on the selected candidate’s education, experience, skills, and overall qualifications.Education:Required: Bachelor’s Degree or above in a Scientific discipline or 2+ years QA experience in a regulated industryPreferred: Bachelor's Degree or above in a Scientific discipline with 5+ years QA experience in a regulated industryExperience:Experience in cGMP in a pharma manufacturing facility2 years’ experience in writing deviations and investigations2 years’ conducting walk throughs using checklistsCompleting Control Document revisionsConducting InspectionsExperience ensuring operators are adhering to safety procedures and company policiesWHY 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!SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.