Senior Specialist, Technical Quality Position Available In Chester, Pennsylvania

Job Description:

A career at Resilience is more than just a job – it’s anopportunity to change the future. Resilience is atechnology-focused biomanufacturing company that’s changing the waymedicine is made. We’re building a sustainable network ofhigh-tech, end-to-end manufacturing solutions to better withstanddisruptive events, serve scientific discovery, and reach those inneed. For more information, please visit www.resilience.com

Position Summary:

The Senior Specialist, Technical Quality (IDAP)will play a pivotal role in ensuring the technical and operationalquality of products, driving continuous improvement inmanufacturing processes, and ensuring compliance with regulatorystandards. This position is responsible for QA activities thatdirectly support the inspection, assembly, and packaging ofpharmaceuticals and combination products with a medical deviceconstituent part. This position requires a blend of strongtechnical expertise, quality assurance knowledge, and leadershipcapabilities to effectively collaborate across departments and leadinitiatives that enhance product quality and process efficiency.

This position provides quality oversight of validation,investigations, and technology/design transfer.

PositionResponsibilities:

Provide quality oversight for investigations,validation, and technology transfer, ensuring adherence toestablished specifications, procedures, and regulatoryrequirements. Provide quality oversight, review, and approval ofinternal validation documents including validation plans,requirement documents (URS, FS, SRA, SLIA, and ACA), protocols,data analysis, discrepancies, and final reports. Represent theTechnical Quality group in project teams, audits, and inspections,as required. Provide hands-on support and act as an SME duringinternal, regulatory, and customer audits and inspections. Performreviews and approvals of investigation initial impact assessmentsto determine the classification of deviations. Provide qualityoversight, review, and approval for deviations, CAPAs, ChangeControls, and various risk assessments. In conjunction with theLead Investigator, lead major/critical investigations andresolution of product quality issues and non-conformances, ensuringtimely and effective corrective actions. Drive and support thedevelopment and implementation of continuous improvementinitiatives to enhance product quality and manufacturingefficiency. Ensure manufacturing operations comply with local andglobal regulatory standards, including but not limited to GMP, FDA,EMA, ISO, and ICH guidelines. Collaborate with MSAT, ProjectManagement, Engineering, and other departments to ensure seamlessintegration of new products and technologies into the manufacturingprocess. Assist in the review and approval of new productintroductions, ensuring quality standards are met throughout theproduct lifecycle. Lead risk assessments (e.g. pFMEA) and implementstrategies for mitigating technical and quality risks associatedwith manufacturing processes.

Minimum Qualifications:

Strongtechnical experience in the qualification of equipment, utilities,facilities, technology transfer, statistical analysis,investigation techniques, development, and risk managementmethodology and process validation, and/or Quality oversight inthese disciplines. Thorough knowledge of current industry bestpractices and regulatory guidance expectations regarding technologytransfer and validation. Demonstrated experience in a regulatedenvironment (21 CFR 210, 211, 4, 820, ISO 13485, ISO 14971, EMA,PDA, ICH, etc.) Knowledge of Design Controls and experience withchange management Strong leadership, relationship management, andorganizational planning. Experience supporting audits andregulatory inspections. Experience using risk assessment tools(e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysisand Critical Control Points (HACCP), Layers of Protection Analysis(LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools,etc.). Expertise in quality management systems. Excellentproblem-solving skills and the ability to work under pressure in afast-paced environment. Strong interpersonal skills with theability to lead cross-functional teams and influence without directauthority. Excellent written and verbal communication skills,including technical writing for documents and reports. Ability andwillingness to learn and adapt skills for various areas. Ability totravel approximately 5-10% based on project demand. Must haveproficient computer skills and be experienced in Microsoft Office,including Word, Excel, PowerPoint, and Outlook.

PreferredQualifications:

Bachelor’s degree or higher in PharmaceuticalSciences, Chemistry, Engineering, Life Sciences, or related field.

Combined experience in quality assurance and/or validation within aGMP regulated pharmaceutical and/or biotechnology manufacturingenvironment. Direct experience with GMP regulatory requirementsrelevant to pharmaceutical manufacturing. Proven track record intechnical troubleshooting and root cause analysis. Prior cGMPinspection, medical device assembly, and/or packaging manufacturingexperience. Experience within a multi-product facility. Experiencewith sterile manufacturing processes. Working knowledge of cGXPrequirements for the manufacturing and inspection of pharmaceuticalproducts and medical devices a strong familiarity with productionoperations. The items described here are representative of thosethat must be met successfully to perform the essential functions ofthis job. Resilience is an Equal Employment Opportunity Employer.

Qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex, sexual orientation,gender perception or identity, national origin, age, maritalstatus, protected veteran status, disability status, physical ormental disability, genetic information, or characteristic, or othernon-job-related characteristics or other prohibited groundsspecified in applicable federal, state, and local laws. Requestsfor reasonable accommodation can be made at any stage of therecruitment process. Resilience offers employees a robust totalrewards program including equity, an annual cash bonus program, a401(k) plan with a generous company match and our benefits packagewhich is thoughtfully designed to support our employees with greathealthcare (including medical, dental and vision), family buildingbenefits, life and disability insurance, flexible time off, paidholidays, other paid leaves of absence, tuition reimbursement andsupport for caregiving needs. Our target base pay hiring range forthis position is $70,000.00 – $115,000.00 per year. Actual base payis dependent upon a number of factors, including but not limitedto, the candidate’s geographical location, relevant experience,qualifications, skills and knowledge. Excited about Resilience andthe biomanufacturing revolution? We encourage you to apply andstart a conversation with one of our recruiters.