Quality Assurance Specialist, Stratatech (Madison WI)

Mallinckrodt - Madison, WI3.4

Full-timeEstimated: $44,000 - $57,000 a year
EducationSkills
The Quality Assurance Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls.

Essential Job Functions:
1. Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.

2. Perform internal and external audits as assigned.

3. Review and release raw materials, intermediate products and finished products.

4 Perform review and approval of OOS, deviations, nonconformance, and investigation as required.

5. Ensure systems are in compliance with current SOPs.

6. Assist investigations and resolve potential product quality issues to improve efficiency.

7. Assist with writing, revising, and approving standard operating procedures.

8. Review and approve SOP, protocols and reports as necessary.

9. Coordinate and/or conduct GMP training.

10. May perform additional duties as required.

Essential Job Requirements:
1. Bachelors’ degree in a scientific discipline.

2. At least 2 years experience in cGMP environment within relevant Quality Assurance/Compliance functions.

3. Excellent writing/communication skills.

4. Training experience a plus

5. Ability to travel is required.

Principal Responsibilities

Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product
Review and release raw materials, intermediate products and finished products
Coordinate and/or conduct GMP training
May perform additional duties as required
Perform internal and external audits as assigned
Perform review and approval of OOS, deviations, nonconformance, and investigation as required
Coordinate and/or conduct GMP training
Generate, publish, and manage quality systems metrics to drive continuous improvement
Coordinate CAPA, OOS, deviations, nonconformance, and investigations
Assist with revising and developing standard operating procedures
May perform additional duties as required

Department specific/Non-essential responsibilities:
Scanning/archiving of GMP documents
Minimum Requirements

Experience / Skills:
Bachelor’s, or higher, degree in a scientific discipline, preferable biology or chemistry
2+ years of experience in a cGMP Quality Assurance/Compliance environment
Excellent writing/communication skills
Proven ability to work independently with little supervision.
Ability to travel is required

Competencies:
Proficient with Microsoft Office tools, especially Excel
Technical writing

Organizational Relationship/Scope:
The Quality Assurance Specialist II collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Clinical Quality, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. This position reports directly to the Quality Assurance Manager. It is the expectation this position works during normal business hours M-F, but may be required to work extra hours or on weekends or holidays in order to support Manufacturing and Lot Release activities.

Working Conditions:
The Quality Specialist II will mainly work in an office environment but will also be required to work in ISO Class 7 manufacturing and QC environment when providing QA support to those functional areas.

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