Manufacturing/Production Jobs

Job Overview

Location: Norwood, MA

Duration: 6 Months

Consultant Title: Sr. QC Compliance Specialist

Job Details

• Lead and oversee the QC area inspection readiness program, performing routine walkthroughs and area reviews; provide feedback on compliance gaps and recommend plans for correction.
• Quality Control Compliance Senior Specialist / Manager will be responsible for and involved in various aspects of QC compliance including inspection readiness activities, quality systems, training and document control. The successful candidate will be required to work with a broad team including QA, Analytical Sciences & Technology, Global QC, Digital Lab Systems, Manufacturing, and Global QC. Accordingly, this position will be expected to work in a highly collaborative, cross-functional manner and provide compliance guidance and oversight to the entire QC department.
• Work with the QC Review and Document Control teams to ensure all laboratory testing and support documentation is reviewed, closed out and archived within appropriate timeframes per established procedures.
• Track, monitor and report on compliance related metrics in various forums, including presentations to key leadership and stakeholders.
• Revise QC SOPs, forms, work instructions and other documentation as required to ensure clarity of procedures, appropriate level of instructions and compliance to regulatory requirements
• Author and/or participate in QC related deviations, OOS investigations and lab events.
• Accept, complete, and report on special assignments within the agreed upon timeframe as assigned.
• Perform various document reviews as the QC Compliance stakeholder, as assigned.
• Perform all job functions with adherence to all relevant procedures, GxP, cGMP and associated regulatory requirements.
• Lead and/or participate in the implementation of meaningful and effective corrective actions for deviations, OOS investigations and lab events.
• Identify areas within QC for continuous improvement, propose compliant solutions and independently implement.
• Represent QC Compliance in cross-functional meetings regarding inspection readiness, deviations, CAPAs and change controls.

Here’s What You’ll Need (Minimum Qualifications)

• Excellent ability to communicate in a scientifically sound and understandable manner.
• B.S. degree in relevant scientific discipline.
• Previous experience in a laboratory compliance function within QC or QA.
• Here’s What You’ll Bring to the Table (Preferred Qualifications)
• Excellent technical writing skills and experience authoring deviations, investigations, and procedures in a cGMP setting.
• Knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
• Minimum 5-8+ years of QC and/or QA experience in a pharmaceutical cGMP setting.
• Demonstrated ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment effectively and independently.
• MS in a relevant scientific discipline with 2-5+ years QC and/or QA experience in a pharmaceutical cGMP setting.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Ability to navigate through ambiguity and rapid growth and adapt to change.

SRG ED&I and EEO Statement

• ED&I: Impellam Group and its brands are equal opportunity employers committed to diversity and inclusion.
• EEO Statement: Impellam Group is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.