Astellas Pharma Sr. Associate, Product Quality Operations in Northbrook, Illinois
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
This position is primarily responsible for the execution of the Annual Product Quality Review process for all Astellas products in the Americas Region. Responsible for ensuring Astellas and vendor compliance with federal regulations, corporate standards, and procedures for Annual Product Quality Reviews for both drug substance and drug product. Additional responsibilities include QA closure activities for the Change Control of Text and Artwork (CCTA) process. This position will also provide support to batch release for distribution activities.
Essential Job Responsibilities:
Executes the Annual Product Quality Review (APQR) process as an individual contributor, which includes collecting information from external and internal manufacturing plants, performing an initial review to identify any potential trends, and enters required information into TrackWise as defined in applicable SOPs.
Interacts with manufacturing plants to resolve concerns with cGMP processes, change control, and documentation.
Coordinates review of APQR information with appropriate Quality Assurance and Technology stakeholders to ensure accuracy of the data within the record.
Coordinates review and approval activities with stakeholders and management to ensure APQRs are completed in a timely manner
Executes closer role for CCTA by collaborating with CMO QA and RA labeling groups to facilitate closure of CCTA child records in a timely manner.
Provide support as requested for batch record review and release for relevant products
Support QA Operations initiatives for deviations, QDR's and CAPAs as required.
Identifies issues and initiates corrective action as required.
Responsible for the storage and maintenance of records (hard copy and electronic) associated with job responsibilities.
Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., SOPs, WPDs, STLs, etc.) as necessary.
This position is primarily responsible for the execution of the Annual Product Quality Review process for all Astellas products in the Americas Region. Additional responsibilities include QA closure activities for the Change Control of Text and Artwork process. This position will also provide support to batch release for distribution activities.
This position reports to the Director, Product Quality Operations and has no direct reports
Minimum BA / BS or equivalent with 3 -- 4 years of industry experience with a minimum of one year of QA experience.
Knowledge of cGMP and other regulations as required relating to Quality Assurance
Effective communication and interpersonal skills, attention to detail and understanding current trends of industry standards relating to Quality Assurance.
Must be able to represent the company to external stakeholders during vendor audits.
Experience in a pharmaceutical manufacturing environment.
Experience in TrackWise
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Quality Assurance
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans