Easter Seals Jobs

Job Title: Quality Systems Manager

Job Description

The Quality Systems Manager will work across four different departments, requiring excellent communication skills. The role involves implementing a new Electronic Quality Management Control System (EQMCS) called Master Control. Responsibilities include conducting internal and supplier audits quarterly and occasionally traveling to supplier sites for these audits.

Responsibilities

• Stay updated on industry trends, developments, and technological advances in QA processes. Integrate this knowledge into the company's quality system standards.

• Maintain records of complaints and non-conformance observations, including root-cause analysis and corrective actions.

• Conduct routine audits of internal and external operations to ensure compliance with cGMPs, SOPs, safety, and government regulations.

• Monitor and document quality assurance activities through internal audits and reporting.

• Plan, execute, and oversee product inspection and testing to ensure quality and conformance to specifications.

• Develop improved production and design standards and create testing protocols for implementation across all service lines.

• Track, document, and report on supplier quality levels to assist operations.

• Monitor and report on production quality, non-conformance, trends, and underlying causes of defects.

• Identify training needs and ensure companywide training is conducted.

• Investigate product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements.

• Monitor risk-management procedures, maintain problem logs, and report issues to managers and product developers.

• Ensure compliance with federal, state, local, FDA, cGMPs, and organizational laws, regulations, guidelines, and best practices.

• Provide training and support to team members on systems, policies, procedures, and core processes.

• Support Regulatory Affairs, including compiling CMC documentation for FDA submissions, reviewing CMC submissions, assisting in the registration and listing of facilities and products, and compiling manufacturing and control changes documentation, including stability data for MCSRs.

• Perform other duties as assigned.

Additional Skills & Qualifications

• Bachelor’s degree (or equivalent) in a relevant field.

• Professional certification, such as Six Sigma, or ASQ preferred.

• 3-5 years of Quality Assurance experience, preferably in a pharmaceutical production facility.

Work Environment

The role involves prolonged periods of standing and walking through the manufacturing suite, as well as prolonged periods of sitting at a desk working on computers. The candidate must be able to lift up to 50 pounds and have the visual acuity to inspect products and machinery. Occasionally climbing stairs may be required. The work environment is a clean and organized lab space within a stable and growing company that has experienced multiple revenue-breaking years. The company values stability and growth, providing a supportive management structure.

Pay and Benefits

The pay range for this position is $31.25 - $40.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Omaha,NE.

Application Deadline

This position is anticipated to close on Feb 28, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.