Specialist II, Quality Systems

BioSpace; East Norriton Township (Montgomery County); On-site; USD 65,000 - 87,500; Full time

Benefits offered by this job

Annual cash bonus

401(k) plan with company match

Flexible time off

Tuition reimbursement

Job summary

A leading biomanufacturing firm in East Norriton, PA, seeks a Quality Systems Specialist to develop and maintain a compliant GMP quality management program. Responsibilities include administering quality systems, managing controlled documents, and supporting internal and client audits. Ideal candidates will possess a relevant B.S. degree, quality experience, and proficiency in Microsoft 365. Compensation for this role ranges from $65,000 to $87,500 annually. Sponsorship for work authorization is not available.

Qualifications

• Demonstrated quality experience and effective collaboration.
• Knowledge of quality systems and software applications.
• Working knowledge of GxP Regulatory requirements.

Responsibilities

• Administer, maintain, and improve core quality systems.
• Review and manage controlled documents throughout their lifecycle.
• Support internal audits, client audits, and regulatory inspections.

Skills

Collaboration and influence

Quality systems knowledge

GxP Regulatory knowledge

Microsoft 365 proficiency

Education

B.S. in relevant discipline

Job description

Position Summary & Role

This role is accountable for developing and maintaining a compliant, well‑organized, and effective GMP quality management program at a highly digital manufacturing plant. The responsibilities for this role will cover all aspects of a GMP Quality Systems, including training, document management, deviations, CAPAs, and change controls. The Quality Systems Specialist is a key quality function and reports to the Quality System Lead. The position will be located in East Norriton, PA.

Job Responsibilities

• Administer, maintain, and improve core quality systems such as Document Management System, Learning Management Systems, and Quality Management Systems
• Review, route, and manage controlled documents, SOPs, Forms, throughout their lifecycle
• Assist with document disposition activities and act as site Business Process Owner (BPO), as needed.
• Author and review technical documents including but not limited to SOPs, various quality reports.
• Support internal audits, client audits, and regulatory inspections
• Support additional Quality initiatives both inner and interdepartmentally, as needed
• Support onboarding of new employees across the site
• Assist with training activities and act as site Business Process Owner (BPO), as needed.
• Manage and execute quality system processes including procedures, validation, deviation management, change control, CAPAs, etc.
• Maintain and organize the controlled document archive, ensuring timely filing, version control, and secure retention in compliance with cGMP, regulatory, and internal quality system requirements

Minimum Requirements

• Demonstrated quality experience and the ability to collaborate with and effectively influence others.
• Knowledgeable with quality systems/software applications.
• Working knowledge of GxP Regulatory requirements.
• Proficient with Microsoft 365 products (Word, Excel, PowerPoint, Outlook)

Preferred Requirements

• B.S. in a relevant discipline (medical, biochemistry, biology, biochemical engineering, or related field).
• 2-5 years relevant life sciences quality experience within quality and/or quality related functions.
• Minimum of 2 years of QA systems experience.
• Hands‑on experience with the management of Quality records (e.g., deviations, change controls, CAPAs, etc).
• Experience with Computer Systems Validation.
• Experience in preparation and participation in client audits or regulatory authority plant/site inspections.

Other Ideal Personal Characteristics

• Performs with integrity.
• Excellent oral and written communication skills.
• Comfortable in a fast‑paced, collaborative company environment and able to adjust workload based upon changing priorities.
• Reputation for superior customer service.
• Driven to reduce complexity and create simple and organized data systems.
• Proficiency in creating high quality procedures that are easy to read and understood.
• Desire and interest to leverage new technology and innovative information management tools

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

Equal Employment Opportunity

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.

Benefits and Compensation

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, 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 $65,000.00 - $87,500.00 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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.