Quality Coordinator (1st Shift)

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia, Northern (Philadelphia County, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

PCI Pharma Services is seeking a Quality Coordinator for 1st shift at our Philadelphia, PA site. The role supports coordinating quality activities to ensure timely, compliant production and release of materials.

You will review batch records for cGMP compliance, prepare and distribute documentation, and act as a point of contact for questions on batch records while supporting continuous improvement and adherence to PCI policies.

Qualifications

• High school education with exposure to cGMP environments is expected.
• A college degree with a scientific focus is preferred.
• Strong organizational, time management and multitasking skills are essential.
• Proficiency with MS Office and Master Control; ability to create and interpret data tables and charts; Lean Six Sigma training is a plus.

Responsibilities

• Prepare and distribute required documentation for requested production work orders.
• Perform documentation review of completed orders to ensure cGMP compliance and customer requirements.
• Review customer standards, procedures and specifications for dissemination relative to batch records and material specs.
• Prepare customer samples for shipment according to approved shipping instructions.
• Submit batch records and documentation to customers to facilitate product release.
• Organize internal and customer approval of batch records and specs.
• Review records to ensure compliance with cGMP and customer requirements.
• Identify, communicate, track and resolve document-related issues with other departments and customers.
• Serve as a customer contact for batch record questions and comments.
• Initiate supplier non-conformance reports and implement material control actions.
• Prepare planned deviation requests when needed.
• Adhere to PCI and cGMP policies and regulations.
• Attendance is an essential function of this job.
• May perform duties of Quality Auditor as assigned.

Skills

Organizational skills

Time management

MS Office

Master Control

Lean Six Sigma

Problem solving

Education

High school diploma

Science degree preferred

Tools

Master Control

MS Office

Job description

## Quality Coordinator (1st Shift)Apply: Philadelphia, PA, USA: Full time: Posted Today: JR119931Life 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, PA****Shift: 1st Shift** **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. **ESSENTIAL DUTIES AND 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/EDUCATION AND EXPERIENCE:*** 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.*