Massachusetts Green Jobs

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose

The Senior Product Quality Assurance (PQA) Analyst has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between AbbVie regulatory areas and TPM plants for regulatory submission.

This function also is the primary person to audit batch records for product manufactured by TPM plants and enter required ba

Responsibilities

• Maintains an effective liaison and cooperative relationship with other AbbVie Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.

• Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by AbbVie QA Operations.

• Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.

• Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.

• Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.

• Participates in Trend Review Board to monitor process track and trending.

• Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.

• Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.

Qualifications

• Bachelor’s degree preferably in Engineering or Science

• Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process

• Knowledge of GMP regulations and standards affecting pharmaceutical products

• Comprehensive knowledge and application of business and quality concepts

• Strong analytical skills and attention to detail

• Change plan, Exception Reports, SAP and LRMS experience is highly preferred

• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences

• Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization

Additional Information

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

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• 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. ​

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Note: No amount of pay is a 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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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.