Quality Control Investigator - Biotechnology

Quality Control Investigator Job Opportunity

Location : Fully Onsite Malvern, PA

Shift: 1st Shift (M-F)

Compensation: $38.46hr to $48.08/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Required Skills & Experience

• Minimum of a bachelor’s degree is required

• Minimum of 2-4 years of experience doing QC lab investigations within GMP environments

• Hands on experience owning and managing deviations, root cause analysis, and CAPAs

• Skilled in basic and advanced analytical methodologies within the functional laboratory is required

• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required

• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required

• Proficiency in using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required

Nice to Have Skills & Experience

• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is preferred

• Detailed knowledge and experience in applying statistical concepts to laboratory data is preferred

• Proficiency in performing technical writing is preferred.

• Ability to independently perform project management functions is preferred

• Basic knowledge of Johnson & Johnson Quality and Compliance standards is preferred

Job Description

The Analyst Quality Control Lab Services position supports the overall QC organization and is responsible for authoring nonconformance investigations and corrective and preventative action records, document management, investigation and assay trending, root cause problem solving, and human performance factors analysis. This position requires analytical thinking, organizational leadership, and technical writing skills. This position will drive improvements within a global organizational framework.

Responsibilities:

• Performs and documents all QC investigations (non-conformance, deviations, invalid assays)

• Authors and execute corrective and preventative action records

• Tracks deviations and events and provides reports to management on trending, and status as requested. Recommends corrective actions for any trends identified

• Manages change through chance control process

• May perform Gap Assessments for local QC documents against new standards and other quality documents

• Executes CAPAs when required for the Quality Control organization

• Works with compliance to provide QC input for the APR

• Reports data from QC as required for the site management review

• Maintains individual training completion in a compliant state

• May be asked to participate in audits

• Support Health Authority inspections • Provide input to functional laboratory meetings

• Make decisions as a QC representative at cross-functional meetings

• Provide leadership and insight as a member of global project teams

• Provide QC input as a member of Quality focused projects