Associate II, Quality Assurance (Night Shift)

RESILIENCE US INC • Hamilton, OH • 1w ago

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
Position Summary:
This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. 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.
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. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
Position 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
Hours (Night Shift):
6pm - 6:30am
2/2/3 Schedule (12-Hour Rotating)
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 quality assurance/regulatory affairs is desirable
Previous experience in a Lean, process-centric organization with emphasis on continuous improvement
Multi-site / multi-functional experience
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
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, nati

Similar Jobs

Security Officer - Industrial Patrol Specialist

Allied Universal • Cincinnati, OH • 19min ago

Legal & Paralegal

Allied Universal®, North America's leading security and facility services company, offers rewarding careers that provide you a sense of purpose. While working in a dynamic, welcoming, and collaborative workplace, you wil...

19min ago

Go to Apply

Senior Project Manager - Civil Engineering

Langan Engineering & Environmental Services • Cincinnati, OH • 1h ago

Management & Administrative

Langan provides expert land development engineering and environmental consulting services for major developers, renewable energy producers, energy companies, corporations, healthcare systems, colleges/universities, and l...

1h ago

Go to Apply

Forklift Operator 2nd Shift (Stand-Up & Sit-Down Required)

PAC Worldwide Corporation • Middletown, OH • 1h ago

Manufacturing & Warehouse

Description Job Title: Warehouse Associate I Shift: 2nd shift (4pm to 12am) Pay: $18.50 + $1.10 shift differential Location:Middletown, OH Job Summary: The warehouse associate will be responsible for operating a forklift...

1h ago

Go to Apply

Purchasing Agent

Veterans Affairs, Veterans Health Administration • Cincinnati, OH • 1h ago

Management & Administrative

Summary This position serves as a Purchasing Agent for the Logistics Service within the VA Health Care System, Cincinnati VAMC performing work to acquire supplies, services, and construction by purchase, rental, or lease...

1h ago

Go to Apply

Dentist-Oral Maxillofacial Surgeon

Veterans Affairs, Veterans Health Administration • Cincinnati, OH • 1h ago

Hospital & Medical

Summary The Cincinnati, OH VA Medical Center is seeking a highly qualified full time Oral Maxillofacial Surgeon. This is an OPEN CONTINUOUS ANNOUNCEMENT. Applications will be accepted on an ongoing basis and qualified ca...

1h ago

Go to Apply

Shift Manager Maintenance

CLEVELAND-CLIFFS STEEL CORPORATION • Middletown, OH • 1h ago

Retail & Hospitality

Cleveland-Cliffs Steel has an immediate opportunity for Shift Manager Maintenance at our Middletown operation. The Shift Manager Maintenance is responsible for supervising and providing work direction to hourly union emp...

1h ago

Go to Apply

Retail Sales Associate

Puma North America, Inc • Cincinnati, OH • 1h ago

Retail & Hospitality

YOUR MISSION Provide consistently high standards of customer experience within the Store in accordance with PUMA's Brand Values and service standards, Through effective customer service, individual performance consistent...

1h ago

Go to Apply

PT Operations Admin Customer Service- 5 PM Start

PITT OHIO Express, LLC • Cincinnati, OH • 1h ago

Management & Administrative

PITT OHIO Express LLC US-OH-Cincinnati ID: 2026-3291 Category: Customer Service/Support Position Type: Part-Time Remote: No Overview PITT OHIO, a $900 million, high service, highly profitable, transportation solutions pr...

1h ago

Go to Apply

Senior Rail Engineer

HDR Engineering Inc • Cincinnati, OH • 1h ago

IT & Engineering

At HDR, our employee-owners are fully engaged in creating a welcoming environment where each of us is valued and respected, a place where everyone is empowered to bring their authentic selves and novel ideas to work ever...

1h ago

Go to Apply

Intermodal Equipment Operator

ITS Technologies & Logistics • Sharonville, OH • 1h ago

Overview Launch Your Career with ConGlobal ConGlobal is hiring immediately for a key role in our global supply chain operations. Whether you're looking to grow your career or gain new skills, this role offers paid traini...

1h ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.