Quality Analyst

LSNE Contract Manufacturing • Philadelphia, PA • 10h ago

Reference #: JR115643 Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Quality Analyst Location: Philadelphia, PA. Department: Quality Shift: Day Shift, 8am 430pm Reporting To: Director, Quality Systems Responsible For (Staff): None

Job Summary PCI is seeking a Quality Analyst with a strong background in Quality with the primary function of conducting customer complaint investigations. The individual also performs support functions related to maintaining the overall Quality Management System.

Essential Duties and Responsibilities: Receive communications from customers related to complaints Log complaints into the QMS system Conduct investigations utilizing root cause analysis tools and work with other functional areas to identify the cause and appropriate corrective and preventive actions Draft and peer review customer complaint investigations Communicate directly with clients in resolution of customer complaints Compile metrics for the functional area Assist with compiling information for regulatory filings Responsibility will include some facets of maintaining and improving the overall Quality Management Systems (i.e. internal audits, CAPA effectiveness, change control)

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Required: High school education or at least five (5) years of pharmaceutical or pharmaceutical packaging experience. A college degree with a concentration in a scientific discipline is preferred. Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines. The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., TrackWise). Ability to create, use and interpret scientific tables, charts, and graphs. Prior experience in technical writing and utilizing root cause analysis tools is preferred. Any Lean Six Sigma or process improvement training is a plus Highly developed oral and written interpersonal communication skills to effectively communicate with company management, customers, suppliers, and agencies at all levels. Strong problem-solving skills

LI-KH1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.

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