Senior Specialist, Quality Assurance

BioSpace; Olde West Chester (OH); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Comprehensive healthcare benefits

Job summary

A technology-focused biomanufacturing company in Ohio seeks a Quality Assurance professional to oversee critical QA activities in operations. The role requires extensive knowledge of GMPs and Quality Systems, with responsibility for batch release and regulatory compliance. Candidates should have a degree in quality assurance or regulatory affairs and demonstrate strong communication skills. This position offers a competitive salary range from $70,000 to $115,000, plus a robust benefits package.

Qualifications

• Prior experience in the pharmaceutical industry or Quality Assurance.
• Strong understanding of Quality Systems and the pharmaceutical supply chain.
• Ability to work independently with minimal guidance.

Responsibilities

• Manage QA activities supporting Operations Teams.
• Approve GMP documentation impacting operations.
• Collaborate on quality system applications.

Skills

Knowledge of cGMPs

Excellent communication skills

Problem-solving skills

Ability to coach and mentor

Education

Bachelor’s or master’s degree in quality assurance/regulatory affairs

Job description

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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.

Position Summary

This position is responsible for all QA activities that directly support execution of the process both within the Operations Teams and in assigned areas outside of Operations. These activities may include, but are not limited to, batch release, change control and documentation, SOPs, supplier management, distribution center management, and regulatory interactions.

Job 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
• Accountable for disposition (release or rejection) of semi-finished and finished packaged product.
• Collaborate with and influence 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 Operations/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects.
• Collaborate with and influence other Operations/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.
• Strong collaboration between other areas to ensure consistent application of quality systems/processes across the site.
• Ability to work independently with minimal guidance from management.
• Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration.
• Demonstrate leadership capabilities.
• Train and mentor junior members of the QA organization and provide QA coaching to other non-QA employees within the area supported.
• Strong performance history of consistently meeting or exceeding expectations.
• Hold others accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organization.
• Demonstrate a strong understanding of the technology area to which the individual is aligned.
• Act as an execution lead/process owner for one or more processes.

Minimum Qualifications

• Prior experience in either the pharmaceutical industry, an operations environment, or Quality Assurance.
• Strong demonstrated knowledge of cGMPs, Quality Systems, and the pharmaceutical supply chain environment.
• Excellent oral and written communication skills.
• Strong ability and motivation to learn.
• Strong problem‑solving skills.
• Ability to coach and mentor peers.

Preferred Qualifications

• Bachelor’s degree or master’s degree in quality assurance / regulatory affairs.
• Previous experience in a Lean, process‑centric organization with 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 a benefits package thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $70,000.00 – $115,000.00 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.