Quality Engineer — GMP, CAPA & Process Validation

AbbVie Inc.; Tempe (AZ); Hybrid; USD 85,000 - 110,000; Full time

Job summary

AbbVie Inc. is seeking a Quality Engineer to perform Manufacturing Quality Assurance duties within the plant, including deviation resolution, product impact analysis, CAPA, and SOP approvals to ensure cGMP compliance.

You will support calibration programs, quality improvement initiatives, and cross-functional collaboration with other Quality groups and Plant departments to meet quality goals and regulatory requirements.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering or equivalent related experience.
• 2+ years of experience in Manufacturing, Quality or Engineering.
• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Good negotiation skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Responsibilities

• Assist Validation Engineer in validation and certification of new process equipment and periodic review of certified systems.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Ensure that quality goals are met and all practices comply with policies and regulations.
• Investigate plant events thoroughly and document in the CAPA system; perform product impact analyses and place product on QA hold when appropriate.
• Maintain effective liaison with other Quality areas and Plant departments.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve standard operating procedures and calibration requests with appropriate limits.
• Develop and implement statistical quality programs and ensure acceptance sampling meets quality confidence levels.

Skills

Verbal and written communication

Problem solving

Interpersonal skills

Negotiation skills

Quality/compliance knowledge

Education

Bachelor's degree in Biology, Chemistry, Engineering or related field

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.

Responsibilities

• Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make
  sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience
• 2+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable 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, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html