Chemical Manufacturing Quality Assurance Specialist Jobs

Experience in product management roles in a manufacturing setting

Convert product strategy into detailed engineering requirements for prototyping and final development, working closely with engineering teams

Prepare comprehensive product strategy documents detailing business cases, use cases, technical requirements, revenue projections, and ROI

Excellent writing, editing, presentation, and public speaking abilities

Nice to have: Proven success as a product developer in a nonmanagerial role

Ensure data integrity for the product line across all internal and external platforms

• Minimum of 2-4 years' experience in pharmaceuticals manufacturing, deviation investigation (Root Cause Analysis).

• Strong interpersonal and communications skills; written and oral

• Strong technical writing experience

• Strong planning, organization and multitasking skills

Manufacturing process deviation investigation experience.

Job Title: Manufacturing Quality Assurance Analyst

Remote - Work from HomeNo

Develops working knowledge of established process control systems and when changes or deviations may be required.

Generally, less than 2 years’ experience in area of responsibility.

Gain understanding of and capability in Manufacturing Quality methods, processes and practices.

Assisting with routine inspections for assigned products / components,

Assisting with product and process audits to help verify the quality of production processes,

Experience | Knowledge | Skills

Oversight of site Quality Management systems

Knowledge of or experience in Lean, Six-Sigma or Operational Excellence

Five plus years of demonstrated leadership, feedback, and coaching experience

Root cause analysis and troubleshooting skills

Five (5)+ years of demonstrated leadership, feedback, and coaching experience

Remote - Work from HomeNo

Develops working knowledge of established process control systems and when changes or deviations may be required.

Generally, less than 2 years’ experience in area of responsibility.

Gain understanding of and capability in Manufacturing Quality methods, processes and practices.

With guidance, performs basic Manufacturing Quality duties, including:

Assisting with routine inspections for assigned products / components,

Provide information to corporate Incident Management Team as needed on product information and consumer awareness.

Position Related Job Duties and Key Responsibilities

Technical Skills and Eligibility Requirements

Manage all product and raw water analysis

Maintain all permitting and licensing requirements

Manage the facility pest control program

Conducting audits: You will conduct regular audits to ensure compliance with regulatory requirements, and identify any areas that need improvement.

Competitive Base Salary: $100,000 - $130,000 based on experience

Global organization with over 50 locations|Significant growth opportunities

Healthcare Package: Medical, Dental, Vision

Preparation of First Article Inspection Reports, Customer frozen process management.

Candidates with equivalent education and experience will be considered.

Manage customer returns (TER’s)Customer Specification Review.

Manage customer specific Quality Improvement Plan.

3-5 years of relevant work experience is desired.

Comprehensive communication skills in the English language both verbal and written.

Effective time management and prioritization skills.

Advises quality top management on issues that may affect Steriles / O&T and/or DPI as a whole.

Seven years of managerial experience in the pharmaceutical industry required.

At least three years of pharmaceutical experience in Managerial QA is preferred.

Ensures adherence of Steriles Manufacturing and Packaging to all relevant worldwide regulatory requirements. Provides systems to maintain compliance with these requirements.

Manages and Develops staff in order to realize Environmental Health and Safety (EH&S), Quality and business goals.

Must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.

Prior experience in a people management role strongly preferred.

Attend and present quality metrics at the Site Quality Review Team / Management Review Meetings

Knowledge of all drug products and medical devices and combination products to assure compliance with applicable regulatory requirements

OR Masters Degree with more than 3 years of experience

Strong analytical and problem-solving abilities.

Min to Max Hourly Salary

Min to Max Annual Salary

The union pay ranges can be found on the Seattle Children's website here: WSNA - UFCW

Disclaimer for Out of State Applicants

Relevant experience may be substituted for education requirement. Level is determined based on qualifications relevant to the role.

Qualification of raw materials, components, equipment, utilities, automation, shipping and validation of cleaning and sterilization processes

Train and/or mentor junior employees, including providing insights and education on processes and procedures

Validation (Fill Finish, Oversight, Cleaning, Equipment, CTU/Refrigeration, CMO, CSV)

GMP Start Up activities, including tech transfer, equipment start-up and technical training development programs

Identify gaps in systems and develop feasible plans for correction; participates in regulatory and customer audits

Paid Vacation, Paid Holidays, Maternity and Paternity Leave, Education Assistance, Wellness Programs, Corporate Discounts, among other benefits

Assist and assume responsibility for resources allocated by site Quality Manager with any assigned administrative tasks.

Good working knowledge of Quality Compliance in production/Chemical environments.

Full Benefit Package (Medical, Dental & Vision) that starts your first day

Responsible for addressing and resolving supplier issues and driving formal corrective action supporting positive changes to Omaha CP-FPP site.

Leads the tracking and follow up for Omaha Product/Process NC and RCA action items, also recommends resolution to NC as appropriate.