Quality - QA Shop Floor Specialist

Job Title: Quality - QA Shop Floor Specialist

Location: Warren, NJ 07059

Duration: 6 Months

Pay Range: $32.00 - $35.34/ hr on W2

100% onsite

Work schedule: Wed-Sun: 1stshift

Job Description:

Purpose and scope of position:

• Specialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO)activities in accordance with client policies, standards, procedures, and Global cGMP requirements. This position reports to the Senior Manager of Quality Assurance Operations.
• Functional responsibilities include On-Site coverage of and/or participation in
• QA Shop Floor and Warehouse/Storage Area Walkthrough activities
• Label Printing and Issuance of finished drug product and shipping labels
• Event Triage
• Packout oversight and performance of release-to-market
• Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP/batch related documentation and procedures.

Required Competencies: Knowledge, Skills, and Abilities:

• BS/MS in a related scientific discipline.
• 1-2 years of experience within QA functions in the pharmaceutical industry.
• Thorough knowledge of cGMP in the pharmaceutical industry. Good understanding of the drug development process.
• Knowledge and application experience with batch record review, product disposition/release, change control, SOP review, GMP inspection.
• Good computer skills and working knowledge of common business software.
• Excellent organizational skills.
• Excellent problem-solving, verbal, and written communication skills.
• Must have strong interpersonal and communication skills, be a team player.
• Must be an individual with proven initiative and demonstrated accountability.
• Professional integrity and maturity are required.

Duties and responsibilities:

• Provide Functional QA Oversight of Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
• Participate in Shop Floor and Quality Check Walkthrough programs.
• Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.

Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.

Revise department SOPs, as well as Review and QA Approval of CTDO SOPs

Perform Real time review /approval of executed batch records and Chain of Identity verification.

Responsible for ERP Material Status Changes of production/drug product

Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements.

Supports Risk Assessments/projects as required by senior management.

Education and Experience (as applicable):

• B.S. scientific discipline or relevant college / university degree preferred.
• Equivalent combination of education and experience acceptable.
• Strong knowledge of cGMP Quality and Compliance principles required.
• Clinical and Phase appropriate experience preferred.
• Strong cross-functional collaboration experience required.

Working conditions: (us only):

Review Work is performed in atypical office environment, with standard office equipment available and used.QA Shop Floor Coverage/Lab Walkthrough Work requires standing and walking for up to 90% of the time on a given day. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.