Associate II, Quality Assurance

5 days ago

West Chester, Pennsylvania, United States Resilience Full time

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.

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 (Day Shift):

  • 6 PM-6 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


This position may also include the following conditions:
[Performing Inspection AQLs, subject to passing an eye exam]

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 equity, 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 $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 and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

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