This position performs as Quality Control (QC) Analyst that will primarily provide analytical support for the manufacture, release, and stability testing of drug substance produced at AbbVie DSO.  The requirements for this QC Analyst position are as follows: 

Knowledge:

• Has a general understanding of the analytical techniques used in the QC department within the analysts discipline. o Is still acquiring higher level knowledge and skills

• Has a general understanding of regulatory documents and understands where to get further information or interpretation as issues come up.

• Provides solutions to a limited range of moderately difficult problems.

• Has a general knowledge of GMP principles and requirements. Able to work in close proximity to:

• Chemicals, oils, solvents and drugs • Biological product including controlled substances and toxins

• The handling of drug compounds and excipients

• An environment where gowning and respiraors are required     

Leadership:

• Works under general supervision

• Follows established procedures.

• Work is reviewed for soundness of judgment as well as overall accuracy.

• Identifies and communicated issues as they occur with proposed solutions.

• Maintains a work positive environment through emotional maturity, interpersonal communication and conflict resolution.

• Takes direction, guidance, and constructive feedback form more senior peers. 

• Operates effectively in a fast paced work environment. 

• Understands how actionable plans relate to goals.

• Maintains flexibility in a dynamic work environment.   

Communication:

• Proficient at GMP documentation.

• Effectively communicates technical concepts to peers and management. o Adapts and customizes message based on audience.

• Occasionally collaborates with departments in the conduct of day to day operations including special projects.

• Represents BLI-QC department on cross functional teams within DSO.

• Effectively communicates in a diverse and multicultural environment.

• Effectively communicates with regulatory inspectors with facilitation from DSO management.  

Administration:

• Occasionally communicates on behalf of AbbVie to contract entities. o Communicates AbbVie standards of quality to contract entities. o Works with contract entities during investigation of analytical results.

• Able to understand big picture and how individual tasks affect departmental and site goals. o Completes activities to meet critical objectives.  

KEY DUTIES AND RESPONSIBILITIES:

% of Time  1.  Provide analytical support for the manufacture, release, and stability testing of drug substance produced at DSO                                     50%

2.  Leadership and communication   30%

3.  Regulatory compliance and validation activities  10%

4.  GMP systems support including software support and SOP maintenance  5% 5.  Continuous improvement  5%      

MINIMUM REQUIREMENTS

 Education and Experience:

1. A Bachelors degree in biology or chemistry strongly preferred.

2. Six to ten years experience in a GMP pharmaceutical manufacturing and/or development environment.

 Essential Skills and Abilities:

1. Strong laboratory skills.

2. Microbiology experience preferred.

3. Demonstrated ability to apply analytical methods

4. Demonstrated ability to retain flexibility in a dynamic work environment.

5. Strong commitment to safety.

6. Detail-oriented and self-motivated

7. Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.

8. Good oral and written skills.

9. Ability to interpret and evaluate data and summarize results.

10. Good oral and written skills. 

Able to work in close proximity to:

1. Chemicals, oils, solvents, and drugs

2. Biological products, including controlled substances and toxins

3. The handling of drug compounds and excipients

4. An environment where gowning and respirators are required.