Quality Control Analyst

3 weeks ago

Irvine, United States AbbVie Full time

**Company Description**
**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 chemical/laboratory testing.
- Knowledge in general chemistry testing (GC, HPLC, TOC, pH, UV concentration)
- Able to support manufacturing for testing during different shifts
- 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.
- Adhere to cGMP requirements.
- 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.

**Qualifications** Qualifications**
- Bachelor’s Degree in Sciences, with a minimum of three (3) years of lab experience in a QC GMP environment
- Experience using HPLC, analytical methods, general chemistry is essential for Chemistry Lab.
- Experience in lab investigations, CAPA, Change Control
- 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**
- 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.

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