Quality Coordinator

PCI NH Lyophilization Services of New England Quality Coordinator Philadelphia, PA, USA 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 Coordinator Location: 3001 Red Lion Road, Philadelphia Shift: 1st Shift Job Description Summary : Assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Prepares and distributes required documentation for requested production work orders. Perform documentation review of completed orders to ensure compliance with cGMP’s and customer requirements. Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications. Prepares customer required samples for shipment according to approved shipping instructions. Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. Organize internal and customer approval of batch records and specs. Perform record reviews of completed orders and orders in process to ensure compliance with cGMP’s and customer requirements. Help identify, communicate, track and resolve document related issues with other departments and customers. Function as one of the customer points for comments or questions pertaining to batch records. Initiating supplier non-conformance reports and effectuates material control. Prepares planned deviation requests when needed. Adherence to PCI and cGMP policies, procedures, rules and regulations. Attendance to work is an essential function of this job. May perform duties of Quality Auditor as assigned by Supervisor/Manager. High school education and experience working in a cGMP environment. 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. Must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED 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. #J-18808-Ljbffr