Quality Associate - Pharm

Hawkins Hawkins, Inc. is a formulator, manufacturer, blender, distributor, 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. Learn more about us.

About the role

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.

Responsibilities

• Safety: Takes personal accountability and leadership to support and continuously foster a workplace that promotes safety first for co-workers, customers, communities, and the environment. 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. 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.
• Collaboration: 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 behavior.
• Issue, track, and reconcile regulated documentation, including batch records, labels, and logbooks, to production lines.
• Conduct 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.
• Incoming inspection testing and sampling of raw materials and release based on test results.
• Generate Certificates of Analysis (COAs) and release finished product based on test results.
• Identify, document, and report any quality events, deviations, or non-conformances observed during production.
• Support investigation processes and lead investigations as needed.
• Support and implement changes to processes and procedures at the departmental and enterprise level.
• 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 initiatives.
• Independently develop and recommend improvements to processes or procedures.
• Use creative problem-solving skills to identify, solve, and/or improve processes.

Requirements

• 4-year degree in a science-related field with a minimum of 1 year of experience in an FDA-regulated industry. Alternatively, a High School degree or equivalent and minimum 2 years of experience in an FDA-regulated industry.
• Training and knowledge of cGMP regulations.
• Industry experience must be in a cGMP production environment (preferably Pharmaceutical or Medical Device) with demonstrated proficiency in documentation generation and review.
• Proficient at organization, time management, and multi-tasking.
• Ability to communicate well with all disciplines and levels of the organization.
• Display initiative and troubleshooting skills in stressful situations.
• Able to work independently to juggle multiple simultaneous priorities with minimal supervision.
• Demonstrate ownership for the integrity of data and documentation.
• Able to work efficiently, independently, and as part of a collaborative team.
• Sound problem-solving skills.

Pay

Expected compensation: $24.00–$25.00/hour, plus 5% bonus eligibility.

Schedule

Expected shift hours: 7 a.m. to 3:30 p.m.

Benefits

Hawkins offers eligible employees and their dependents comprehensive benefits, including:

• Medical, dental, and vision insurance
• Life insurance, long-term disability (LTD), and short-term disability (STD)
• 401(k) match
• Employee Stock Purchase Program (ESPP)
• Paid time off and paid holidays

For more information on Hawkins benefits, visit: https://www.hawkinsinc.com/careers/benefits/.