Compliance Specialist Jobs

About The Position

Requirements

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum (3) years of experience in the biopharmaceutical industry within a cGMP Quality Control role
• Successfully interface with multi-disciplined teams in a global setting
• Extremely detail-oriented with strong analytical, written, and verbal communication skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Flexible and adaptable style with an eagerness to take on challenges
• Problem solver who not only identifies issues but leads efforts to resolve

Nice To Haves

• experience with cell and/or gene therapy products is a plus

Responsibilities

• Performing Quality Control documentation and data management, including issuing testing forms, data filing and data storage.
• Assist with Quality Control Documentation Project by locating, organizing and compiling documentation files, creating binders, and executing a high volume of standardized, repetitive tasks daily.
• Maintaining lot lifecycle in LIMS by logging in batches, entering data, reviewing data and reviewing batches.
• Creates QC testing Certificates of Analysis (CoA) and Certificates of Testing (CoT) to support the release of final products, both internally and externally.
• Assist with tracking the status of quality records within QC to ensure on-time completion.
• Escalates roadblocks to completion of records and provides potential solutions.
• Perform miscellaneous duties as assigned.

Benefits

• As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.