QA Supply Chain Specialist
King of Prussia, PA
Full Time
Quality Assurance
Mid Level
Company Overview:
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.
Position Summary:
SK pharmteco, Cell and Gene North America is seeking a Quality Assurance Supply Chain Specialist/Senior Specialist to provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to the end-to-end Supply Chain activities to meet SKPT's standards and regulatory expectations. These include quality support of materials management including receipt, storage, release, distribution, logistics, supplier complaints, and internal investigations. The role will provide timely decisions and consultations in alignment with cGMP, SKPT, and regulatory guidelines.
Primary Responsibilities:
SK pharmteco (SKPT, the Corporation) is a U.S.-based global Contract Development and Manufacturing Organization (CDMO) that consolidates the operations of sites worldwide – Korea, France, Ireland, and the United States (CA and PA). Built on over 75 years of experience, SK pharmteco is a trusted partner specializing in the manufacture of small molecule APIs and intermediates, viral vectors for gene therapies, cell therapies, registered starting materials and analytical services for the pharmaceutical industry worldwide.
Position Summary:
SK pharmteco, Cell and Gene North America is seeking a Quality Assurance Supply Chain Specialist/Senior Specialist to provide quality oversight on compliance and Good Manufacturing Practice (GMP) that pertains to the end-to-end Supply Chain activities to meet SKPT's standards and regulatory expectations. These include quality support of materials management including receipt, storage, release, distribution, logistics, supplier complaints, and internal investigations. The role will provide timely decisions and consultations in alignment with cGMP, SKPT, and regulatory guidelines.
Primary Responsibilities:
- QA support to the SKPT Supply Chain end-to end materials management program, including processing of supplier complaints, material receipt and release, inventory control, shipping, and distribution.
- Create material inspection plans in SKPT’s internal inventory management system.
- Maintain and manage raw material retains.
- Escalate to Quality Management any quality and business risk(s) to SKPT posed by materials suppliers.
- Conduct, execute and document thorough investigations and CAPAs. Ensure timeliness of deliverables through proactive intervention. May own CAPA action items or deliverables.
- Troubleshoot quality/compliance issues, using experience, ingenuity, and creativity to provide solutions to a wide range of root causes.
- Supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, and actions.
- Maintain metrics.
- Support management reviews and other presentations.
- Maintain knowledge of regulatory environments, cGMPs, FDA policies and current industry trends.
- Engage in cross functional organization to develop policies and processes to comply with new cGMP, USP, and CFR requirements/guidance at the site.
- Implement safety, quality and compliance improvement programs and initiatives. Innovate solutions to minor quality system gaps and participate in continuous improvement projects.
- Responsible for revising established processes and procedures which may impact multiple functions or regions.
- Other duties, as assigned
Education & Experience:
- Bachelor’s Degree or higher
- Specialist (3-5 years) and Senior Specialist (5+ years) of experience in cGMP supplier and materials management, preferably in a quality assurance role.
- Strong knowledge of cGMP inventory management systems, particularly SAP.
- Strong collaborator, internally and externally, with exceptional time management and organizational skills
- Proven team player, with the ability and desire to grow within the SKPT organization
- Excellent written and verbal communication skills.
- Excellent analytical, prioritization, multi-tasking, and communication skills.
- Successfully drive projects forward to meet program/project deliverables.
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
- Ability to work effectively on cross functional teams
Physical Requirements:
- Ability to lift up to 25-50 lbs at times.
Note: This job description is intended to convey information essential to understanding the scope of the job role. It is not intended to be an exhaustive list of qualifications, responsibilities, and skills required. Additional duties may be assigned as necessary.
SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
SK pharmteco Inc., is an equal opportunity employer who prohibits discrimination and harassment of any type, and affords equal employment opportunities to employees and applicants.
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