Sr. Quality Laboratories Analyst
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
The Sr Quality Laboratories Analyst oversees the processes of the chemical analysis and release of in-process materials and final products. This position requires scientific knowledge and technical expertise in the field of chemistry, technical writing, investigation and problem solving and regulatory requirements. May lead a functional sub-team.
This position is responsible for the following:
- This position operates in a technical environment that requires scientific knowledge and technical expertise in the fields of Chemistry, GMP and technical writing.
- In association with departmental supervision, may direct and execute raw materials, in process, final, stability, and complaint product testing programs.
- Assists departmental supervision in sign-off of testing documentation.
- Conducts laboratory investigations, including out of specification test results.
- May develop and execute Validation Protocols covering instrumentation, laboratory, and manufacturing procedures as they relate to Chemistry Laboratory issues.
- Serves as a functional expert and directs lab technicians in performing protocols.
- Review and revise Chemistry Laboratory Standard Operating Procedures.
- May review and revise Analysis Procedure and Product or Raw Material specifications to maintain regulatory compliance.
- In association with departmental supervision, directs and executes safety programs.
- Assists supervision in implementing a continual improvement to lab processes.
- Provide troubleshooting to support Quality Assurance and Manufacturing to assess new and existing processes and technologies.
- When required, support supplier audits/appraisals, internal, and regulatory audits.
- Performs other duties as assigned
Education and Experience:
- Bachelor’s Degree in Chemistry or related Science.
- Five (5) years of lab experience in regulated environment, pharmaceutical experience is preferred.
- Working knowledge of HPLC and GC instrumentation, basic troubleshooting and analyses.
- Two (2) years of Team Leadership experience.
- Technical skills: LIMs (preferred), MS Office (Word, Excel, PowerPoint), QMS/Trackwise (preferred).
- Experience working in a GMP regulated environment.
Essential Knowledge, Skills & Abilities:
- Excellent analytical skills and effective problem-solving skills.
- Excellent written documentation skills.
- Proven ability to work effectively with others.
- Good verbal and written communication skills.
- Proficient Microsoft Office skills.
- Proven Leadership skills.
- Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.