Associate II, Quality Assurance (Night Shift)

Resilience; Blue Ash (OH); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Medical, dental, vision insurance

Family building benefits

Life and disability insurance

Paid vacation

Paid holidays

Paid leaves

Tuition reimbursement

Caregiving support

Job summary

Resilience in Blue Ash, OH is hiring an Associate II, Quality Assurance to provide quality oversight across GMP activities, including batch release, change control, documentation, and investigations. You will collaborate with QA teams, support process validation, and ensure regulatory compliance while working on a night-shift schedule.

Bachelor’s degree preferred; QA experience required; strong communication and a continuous-improvement mindset are essential.

Qualifications

• Experience in pharmaceutical QA or operations environment.
• Excellent oral and written communication.
• Strong willingness to learn and adapt.

Responsibilities

• Review batch records and GMP documentation with direct impact on activities and facilities.
• Release products and resolve quality issues to maintain uninterrupted product flow.
• Collaborate with QA teams to ensure consistent application of quality systems.
• Support change control, deviations, investigations, SOPs, and regulatory interactions.

Skills

Quality Assurance

GMP knowledge

Communication skills

Learning agility

Education

Bachelor's degree

Master's degree desirable

Job description

A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Job Description

Position Summary & Responsibilities

The Associate II, Quality Assurance (Blue Ash), is responsible for providing quality oversight and operational support across inspection, assembly, packaging, incoming quality control, and product release activities. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Responsibilities

• Maintain a high level of understanding of relevant production processes and quality systems
• Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
  • Change Requests
  • Batch Records and associated documentation
  • Product and Component Release transactions in SAP
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols and Reports
  • Standard Operating Procedures
• Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives

• Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
• Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders
• Collaborate in data analysis and report creation on quality metrics and key performance indicators
• At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs.

Hours (Night Shift):

• 6 PM-6:30 AM
• 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over

Minimum Qualifications

• Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
• Excellent oral and written communication skills
• Strong ability and motivation to learn

Preferred Qualifications

• Bachelor's degree; master's degree in science is desirable
• Previous experience in a Lean, process-centric organization with an emphasis on continuous improvement
• Multi-site / multi-functional experience

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $60,000.00 - $90,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.