Quality Associate - Pharm

Hawkins Inc; Minneapolis (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

LTD/STD

401(k) match

Employee Stock Purchase Program

Paid time off

Paid holidays

Job summary

Hawkins Inc. seeks a Quality Associate (Pharm) to oversee enterprise-wide quality initiatives, ensuring safety, compliance, and customer satisfaction.

You will implement and sustain the Quality Management System while coordinating with internal and external resources for product qualification. Responsibilities include processing regulated docs, conducting line clearance, reviewing batch records, and supporting deviations investigations, with a focus on continuous process improvements across

Qualifications

• Knowledge of cGMP and regulatory requirements.
• Experience documenting batch records and deviations.
• Investigation skills for quality events and impacts.
• Familiarity with SOPs and change controls.

Responsibilities

• Issue, track, and reconcile regulated documentation, including batch records, labels, and logbooks, to production lines.
• Conducts line clearance and post checks in support of manufacturing activities.
• Verify that all manufacturing and testing activities align with approved SOPs.
• Perform reviews of executed batch records, logs and documentation for accuracy and compliance.
• Perform in-process inspections to resolve problems and ensure regulatory compliance.
• Enter test results, generate COAs, and release finished product accordingly.
• Identify, document, and report any quality events or deviations observed during production.

Skills

Safety

Customer Focus

Accountability

Teamwork

Ethics

Communication

Job description

Hawkins, Inc. is a formulator, manufacturer, blender, distributer, and sales agent for thousands of industrial chemicals and reagent grade laboratory chemicals sold to municipalities and businesses throughout the Central United States. Thousands across a variety of industries have depended on Hawkins for the chemical products they need since 1938.

The position of Quality Associate (Pharm) encompasses an enterprise wide view of Quality and how processes and procedures interact to ensure product safety, quality and compliance to meet customer expectations and internal quality requirements. A Quality Associate is expected to implement processes and procedures to sustain and improve the Quality Management System. In addition, a Quality Associate will collaborate with a variety of internal and external resources to coordinate product qualification activities.

DUTIES AND RESPONSIBILITIES:

• Safety
  • Takes personal accountability and leadership to support and continuously foster a workplace that promotes safety first for our co-workers, customers, communities and the This includes following regulation and compliance standards set by government agencies.
• Customer Focus
  • Knowing the (internal and external) customer business needs and acting accordingly; anticipating customer needs, and giving high priority to customer satisfaction and customer service.
• Professionalism
  • Treats others with dignity and respect. Chooses to commit to honesty, transparency, and working ethically.
• Accountability
  • Follows through on commitments made to Takes ownership for their own actions and has the ability to explain them. Accepts responsibility that results in the anticipation and/or prevention of problem areas from actions, and promotes a solution mindset inside and outside the department.
• Demonstrates behavior that recognizes the value of teamwork both within and outside of their department. Works as a productive member of a cohesive group toward a common goal, and contributes to team development. Demonstrates positive, constructive and professional

Day to day:

• Issue, track, and reconcile regulated documentation, including batch records, labels, and logbooks, to production lines.
• Conducts line clearance and post checks in support of manufacturing activities.
• Verify that all manufacturing and testing activities align with approved Standard Operating Procedures (SOPs).
• Perform reviews of executed batch records, logs and documentation to ensure accuracy, completeness, and cGMP compliance.
• Perform in-process inspections of active production areas to resolve problems early and to ensure compliance with SOP and regulatory requirements.
• In-coming inspection testing and sampling of raw materials and release based on
• Enter test results, generate COA’s and release finished product based on
• Identify, document, and report any quality events, deviations, or non-conformances observed during production.

Required:

• Support investigation processes and leads investigations as
• Support and implement changes to processes and procedures at the
• Investigate and assess the impact of minor and major deviations that may occur during manufacturing, testing or distribution of products.
• Support quality role in development of new

Strategic:

• Independently develop and recommend improvements to process or
• Use creative problem-solving skills to identify, solve and/or improve processes

TRAVEL

Not required

Expected Shift Hours: 7 a.m. to 3:30 p.m.

• Hawkins offers eligible employees and their dependents comprehensive benefits, which includes medical, dental, vision, life insurance, LTD/STD and more.
• Other benefits for eligible employees include 401(k) match, Employee Stock Purchase program (ESPP), paid time off, and paid holidays.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristics protected by law. Hawkins is a Drug Free workplace.

Qualifications

Skills

Behaviors

:

Motivations

:

Education

Experience

Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.