Search Jobs
Sr. Specialist, QC Compliance
Apply Now
Location: Norwood, Massachusetts 02139
Employment Type: Contract
Job Description
Contract Length: 6 months
Job Summary: This person will be responsible for and involved in various aspects of QC compliance including inspection readiness activities, quality systems, training and document control.
Responsibilities:
Requirements:
Job Summary: This person will be responsible for and involved in various aspects of QC compliance including inspection readiness activities, quality systems, training and document control.
Responsibilities:
- 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.
- Identify areas within QC for continuous improvement, propose compliant solutions and independently implement.
- Author and/or participate in QC related deviations, OOS investigations and lab events.
- Lead and/or participate in the implementation of meaningful and effective corrective actions for deviations, OOS investigations and lab events.
- 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.
- 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.
Requirements:
- Minimum 5-8+ years of QC and/or QA experience in a pharmaceutical cGMP setting.
- B.S. degree in relevant scientific discipline.
- 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.
- Excellent ability to communicate in a scientifically sound and understandable manner.
- Demonstrated ability to prioritize, manage and complete multiple projects and tasks in a fast-paced environment effectively and independently.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to navigate through ambiguity and rapid growth and adapt to change.
Can't find your fit?
We get new jobs every day. Send us your resume and we'll let you know when we have the right opportunity for you.