Quality Lab Analyst

The Quality Lab Analyst is responsible for planning coordinating and/or implementing initiatives that provide quality assurance support for QC Lab Operations. Specific areas of support may include: GMP/Compliance; Change Management Lab Equipment/Instrument procurement installation calibration validation/qualification Training and QC Lab support activities (like Testing Stability Program and Data review). This position will help to ensure that the QC Labs operate in compliance with corporate and governmental regulations.

Responsibilities:

Serve as compliance specialist for the QC lab including routine assessment of lab compliance monthly communication to lab management regarding compliance concerns ensure lab managers complete quarterly LIR and data review checklists and serve as coordinator for any lab specific audits as needed.

Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed.

Work collaboratively with multiple parties to ensure appropriate instrumentation is procured installed calibrated and qualified according to company procedures.

Perform review and assessments of QC documents (i.e. methods qualification protocols calibration documents etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement improvements within the quality system.

Lead project teams in planning preparation review and approval of quality documentation related to calibration requests.

Participate on validation review board as area validation for equipment qualifications.

Assist in the design of effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.

May be asked to assist in development revision or implementation (including delivering training) of training modules videos and documents to the local and to global labs.

Support QC Stability Program (Create protocols Sample Placement and Pull)

Lead lab investigations and CAPA

Qualifications :

Bachelors degree in chemistry Pharmacy Biology Microbiology Engineering or other technical/ scientific areas preferred.

4 years experience in quality assurance quality oversight or relevant experience.

Knowledge and familiarity with product testing test method requirements and capabilities of common lab instrumentation is preferred.

Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device biologics and pharmaceutical products preferred.

Experience leading teams delivering tactical results.

Strong oral and written communication skills.

Good interpersonal skills.

Good negotiation skills.

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 shortterm 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. 

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Work :

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