Quality Coordinator

PCI Pharma Services•Philadelphia, PA

About The Position

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. Job Description Summary of Objective: 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.

Requirements

High school education and experience working in a cGMP environment.
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., Mastercontrol).
Ability to create, use and interpret scientific tables, charts, and graphs.
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
Ability to effectively present information to management and customers.
Must have strong interpersonal and excellent communication skills.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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.
Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project.

Nice To Haves

A college degree with a concentration in a scientific discipline is preferred.
Any Lean Six Sigma or process improvement training is a plus.

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.
Other duties as assigned by Supervisor/Manager.