Associate II, Quality Assurance (Night Shift)

Resilience; Port Union (OH); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare plan

Paid time off

Tuition reimbursement

Caregiving support

Job summary

Resilience, a technology-focused biomanufacturing company in Ohio, seeks a QA professional to support process execution. Responsibilities include QA review of GMP documentation, batch release, change control, and deviations within the PET and related areas, ensuring GMP compliance across projects.

You will collaborate with Quality peers, analyze quality metrics, and drive process improvements while maintaining regulatory readiness and documentation integrity in a fast-paced manufacturing

Qualifications

• Experience in pharmaceutical industry, an operations environment, or Quality Assurance.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.
• Lean/process-centric experience with continuous improvement.
• Multi-site / multi-functional experience.

Responsibilities

• Review and approve GMP documentation affecting PET areas.
• Perform batch record review and product disposition to meet site objectives.
• Manage change requests, deviations, investigations, SOPs and related documentation.
• Collaborate with site support groups to ensure GMP compliance during planning and execution.
• Contribute to data analysis and quality metric reporting.

Skills

Quality Assurance

GMP Documentation

SAP

Data analysis

Education

Bachelor's degree

Master's degree in science

Tools

SAP

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.comPosition Summary & ResponsibilitiesThis 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.ResponsibilitiesMaintain a high level of understanding of relevant production processes and quality systemsPerform 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 RequestsBatch Records and associated documentationProduct and Component Release transactions in SAPQuality Investigations (Deviations, Product Complaints)Validation Plans, Protocols and ReportsStandard Operating ProceduresCollaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systemsExecute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectivesInterface 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 projectsCollaborate 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 practicesStay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leadersCollaborate in data analysis and report creation on quality metrics and key performance indicatorsAt 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 AM2 days on, 2 days off, 3 days on, 3 days off and the rotation starts overMinimum QualificationsExperience in either the pharmaceutical industry, an operations environment, or Quality AssuranceExcellent oral and written communication skillsStrong ability and motivation to learnPreferred QualificationsBachelor’s degree; master’s degree in science is desirablePrevious experience in a Lean, process-centric organization with an emphasis on continuous improvementMulti-site / multi-functional experienceSponsorship 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. Excited about Resilience? We encourage you to apply and start a conversation with one of our recruiters.