Job Abstract

Understand Regulations and business processes required to maintain Laboratory Data Integrity. Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements. Responsible for the timely completion of testing. Perform environmental monitoring, bioburden, endotoxin and general microbiology tests. Ensure that all test equipment is used and maintained correctly. Ensure all in-process sampling and testing is completed on time. Maintain up-to-date, complete and p... more details

Job Description

Job Description

Understand Regulations and business processes required to maintain Laboratory Data Integrity.
Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements
Responsible for the timely completion of testing.
Perform environmental monitoring, bioburden, endotoxin and general microbiology tests
Ensure that all test equipment is used and maintained correctly.
Ensure all in-process sampling and testing is completed on time.
Maintain up-to-date, complete and precise records of all tests performed.
Able to support manufacturing for testing during different shifts
Assist in the resolution of quality problems as required.
Develop/update in-house laboratory procedures as appropriate.
Support the transfer of new products.
Adhere to and supports all EHS & E standards, procedures and policies
Support the qualification of new laboratory equipment
Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out – of -specification (OOS) results
Participate in analytical method transfers and validations
Authoring and review of documents such as protocols, reports, test methods, SOPs.

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.

Qualifications

Qualifications

• Bachelor’s Degree in Sciences, with a minimum of three (3) years of lab experience in a QC GMP environment

• Experience in microbiology tests such as bioburden, sterility, environmental monitoring, endotoxin

Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.

Experience in lab investigations, CAPA

• Experience working in a GMP regulated environment

• Ability to articulate clearly when dealing with colleagues, peer groups and managers.
• Proven ability to work independently and autonomously when required.
• Attention to detail.
• Ability to plan and schedule workload.
• Ability to work well under pressure and consistently deliver results while demonstrating an action- orientated approach to overcome obstacles.
• Relevant industry experience preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.?
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?
This job is eligible to participate in our short-term incentive programs. ?

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

Apply with AbbVie, Inc.

Search Terms: Control Analyst, Quality Control, Microbiology, Biology, Microbiology

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