Senior Analyst, Laboratory Quality Control

Performs quality laboratory testing required for the manufacturing process utilities raw materials in process samples and final product following specifications in both the microbiological and analytical laboratories. Performs microbiological and analytical testing such as bio burden endotoxin TOC pH and conductivity to water samples used in the product manufacturing process and to the final product. Performs in process product testing such as bio burden and endotoxin and analytical testing (HPLC Gel Electrophoresis DNA) among others. Performs other microbiological lab testing such as growth promotion and identification of microorganisms. Provides support in method transfer equipment/instrument qualification and process validation.

• Understand Regulations and business processes required to maintain Laboratory Data Integrity.
• Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
• Adhere to cGMP requirements.
• Adhere to and supports all EHS & E standards procedures and policies.
• Responsible for the timely completion of assigned laboratory testing.
• Ensure that all test equipment is used and maintained correctly.
• Able to work independently.
• Perform environmental monitoring in cleanrooms within the manufacturing area.
• Collect water samples throughout the manufacturing facility and test for bioburden and endotoxin.
• Perform bioburden and endotoxin for final drug substance.
• Knowledge in general microbiology preferred (Gram-stain spore stain streaking growth promotion).
• Able to work in an environment where respirator is required to be worn during production for at least 4 hours.
• Position requires constant body movement such as lifting carrying equipment during environmental monitoring pushing carts doors.
• Able to accommodate weekend and holiday work as required by the manufacturing schedule.
• Participate in method transfers and validations as needed.  
• Authoring and review of documents such as protocols reports test methods SOPs.
• Owning and supporting cGMP routine testing by owning quality system records required for deviations laboratory investigations CAPAs and out of -specification (OOS) results
• Support the qualifications of new laboratory equipment.
• Responsible for daily activities such as waste disposal glasswasher autoclave runs
• Able to maintain accurate inventory records of toxin during usage.

Furthermore the position requires the individual to work with and in areas requiring select agents (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. Employment is contingent upon CDC and FBI clearance.

Qualifications :

• Associate degree in science (major in Biology Chemistry Microbiology or Medical Technology) and five (5) years of relevant laboratory experience; or bachelors degree in science (major in Biology Microbiology or Chemistry) and three (3) years of relevant laboratory experience.
• Experience in the general microbial and analytical testing/methodology (e. g. endotoxin bio burden HPLC Gel Electrophoresis).
• Basic knowledge of laboratory techniques and laboratory instruments.
• Basic knowledge of computerized systems.
• Basic verbal and written communication skills in English.

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time