Quality Associate III
About The Position
The Quality Associate III (Quality Engineer) is a key individual contributor responsible for driving quality engineering initiatives and supporting regulatory compliance within a pharmaceutical manufacturing environment. This role leads validation efforts and quality improvement projects, with a strong focus on enhancing and modernizing visual inspection programs for sterile products. The position partners cross-functionally to implement process improvements and ensure compliance to quality standards. This role plays a critical part in advancing product quality and supporting key regulatory and operational priorities.
Requirements
- Bachelor’s degree in Science or Engineering required
- 5 or more years experience in IT, Engineering, Science or related field.
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Strong technical writing skills.
- Must be able to clearly document audit findings within audit reports.
- Strong technical, analytical and problem solving skills.
- Good interpersonal, communication, influencing, negotiation skills.
- Understand scientific strategies and be able to invent new methods or new avenues of investigation.
- Good interpersonal/communication/influencing/negation skills.
- Good project management skills
Responsibilities
- Lead ongoing daily departmental activities for areas of direct responsibility and assist other Quality areas in the successful performance of these activities.
- Drive root cause problem solving for non-conformances in area of responsibility, and champion problems solving on the manufacturing floor.
- Lead multiple process/product improvement projects, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
- Manage activities in achieving defined quality goals in an efficient, accurate and timely manner.
- Ensure business needs and timeliness requirements of the department are met or exceeded.
- Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Partners with other functions, facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations
- Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements.
- Maintain a high level of expertise in current regulatory requirements.
- Demonstrate leadership ability and be recognized by all levels of the facility as a subject matter expert in their area.
- Assists and writes validations, audits and assessments.
Benefits
- medical and dental coverage that start on day one
- insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
- Flexible Spending Accounts
- educational assistance programs
- paid holidays
- paid time off ranging from 20 to 35 days based on length of service
- family and medical leaves of absence
- paid parental leave
- commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- childcare benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
