Quality Coordinator (1st Shift)

About the role

Location: 3001 Red Lion Road, Philadelphia, PA. Shift: 1st Shift. 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.

Responsibilities

• 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.

Qualifications

High school education and experience working in a cGMP environment. A college degree with a concentration in a scientific discipline is preferred.

• Excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
• 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.

Schedule

1st Shift.