QA Systems Specialist

TITLE: QA Systems Specialist

SHIFT: Monday-Friday; 7:00AM - 4:00PM

SUMMARY:

Provide Support and continuous improvement to the Rockline Quality System. The Quality Systems team is responsible for Internal Audits, GMP compliance, regulatory and customer requirement compliance, Sanitation, Pest Control, Nonconformance investigations, CAPA, Customer Complaints, Change Control, and managing HACCP & PCQI certifications. A high level of verbal and written communication skills is required to compile and present data and trends for Quarterly Management Review, Annual Product Review, and Annual Management Review. Rockline Quality Systems comply with cGMP standards for Drug and Medical Device, Cosmetic, Food Safety, Food Contact Packaging and BRCGS standards. Regulatory, Customer, and third party audits are managed by the Quality Systems Department.

ESSENTIAL ACCOUNTABILITES:

• Manage Regulatory inspections, customer and 3^rd party audits - Present documents, answer auditor's question as audit point of contact. Schedule and coordinate audits. Act as point of contact for audits. Ensure corrective actions are completed. Respond to audit findings. Maintain audit files.
• Manage GMP audit program of the manufacturing site and WI warehouses. Represent Quality as needed in the QA/Ops Gemba audits. Schedule audits with area Leaders, photograph and report findings, assign Audit Work Orders as needed.
• Manage CAPA program, ensure CAPAs are effective and closed in a timely manner.
• Manage site QAM initiative
• Manage HACCP and Food Safety programs. HACCP and PCQI Certifications required, ensure compliance with food safety requirements (21 CFR Part 117)
• Interact with Customers and Customer portals for audits, corrective actions, customer satisfaction
• Manage Internal Audit program, the effective implementation and review of Quality procedures through the Rockline, WI Internal Audit System in accordance with Rockline and industry standards. Present quarterly Internal Audit Reports
• Manage Audit Work Order program including the issuance, follow-up on completion, verification, and closure of internal audit work orders.
• Coordinate with Production and other department to discuss, resolve, and eliminate documentation observations.
• Provide guidance to Document Coordinators to process Procedures and Work Instructions, ensure no past due biennial reviews with input from team members.
• Identify, lead or manage quality system document improvements. Improvements to focus on effectiveness, efficiency and when applicable drive simplification. Update documents as needed.
• Drive Rockline QMS continuous improvement initiatives as site representative for Docushare, Agile, other systems
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  Able to demonstrate a motivated approach to work including the ability to plan, prioritize and work under pressure to meet set deadlines with good follow up and documentation skills.

  
  
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  Ability to plan, organize, direct, and manage teams in a problem-solving environment

  
  
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  Determine severity of Quality issues - whether an AWO or CAPA - with QA/QS Manager

  
  
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  Ability to properly interpret 21 CFR 210, 211, 820, ISO-13485, BRC

  
  
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  Must be able to have open communication with all departments to be able to assist with issues that may arise.

  
  

REQUIREMENTS:

• Bachelors Degree required.
  
  
  
  • Science or quality field preferred. (Substantial, equivalent experience in a related field will be considered in lieu of a degree.)
  
  
  
  
• 5 years of relevant experience required.
• HACCP Practitioner certification, CQA and/or PCQI Certification.
• Documentation experience in the life science industries, Pharmaceutical, Biotech, and Medical Device.
  
  
  
  • For example: ISO, cGMP, cGLP, SOPs, CAPA preferred.
  
  
  
  
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  Experience with Electronic Document / Quality systems, such as Docushare, Agile.

  
  
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  Experience with Quality Assurance & Quality Control fields primarily in manufacturing environments.

  
  
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  Thorough understanding of Quality Systems and regulatory requirements (21CFR 210, 211, 820, ISO).

  
  
• Organization and planning, managing multiple priorities, and achieving results.

Preferred Experience:

• ISO, cGMP, cGLP, SOPs, CAPA certifications
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  Quality System Requirements

  
  
• BRCGS Consumer Products Standard
• Document Control (Documentation, Implementation, and Auditing)
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  Internal Auditing Change Control

  
  
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  Certified Quality Auditor (CQA) from ASQ

  
  
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  Proficiency with Microsoft Word, Excel, PowerPoint

  
  
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  Technical Writing skills

  
  

BENEFITS:

• Paid Time Off, Paid Holidays & ETO immediately upon hire
• Medical, Dental, Vision & Prescription Drug Coverage - eligible 1stof the month after 30 days of employment
• Short and Long-term Disability Insurance
• Life Insurance
• FSA/HSA account options
• Fitness Reimbursement
• Tuition Reimbursement
• Many voluntary benefit options
• 401k with company match vested day one
• Employee-only product sales

Come be a part of the People Who Make It Right!

• SCEDC Economic Driver of the Year Award (2021)
• Forbes Magazine - #69 Best Large & Mid-sized Employers in the US (2021)
• Sheboygan County Chamber of Commerce - Safety Leader of the Year (2019)
• Sheboygan County Chamber of Commerce - Manufacturer of the Year (2015)
  
  

Rockline is a smoke-free & tobacco-free workplace.

FLSA: Exempt.

Grade: 10