What are the responsibilities and job description for the Quality Inspector, QC, IQC, QA position at Otsuka Pharmaceutical Companies (U.S.)?
Job Summary
The Quality Inspector role is to support manufacturing quality. Responsible for timely and effective GMP review of production records in order to maintain a continuous flow of records, and to manage and control materials used for the product realization including nonconforming materials. Responsible for Lot release testing.
Job Description
Maintain the effectiveness of Quality Management Systems to assure compliance with GMP: Participates in the implementation of the Quality Management System. Perform manufacturing QC processes in a timely manner including lot release testing and testing related to validation, qualification. Calibration and maintenance of laboratory equipment and related systems, maintenance of laboratory equipment. Assist in the development of QC/QA procedures, Protocols, reports, create and maintain QC/QA documentation for new and existing products, processes, and equipment. Reviews, interprets, and evaluates analytical data, including raw data, of developmental, clinical, and commercial related products for accuracy and compliance within procedures and GxP requirements. Monitors stability studies of developmental, clinical, and commercial related products tested internal or contract laboratories. Analyze and evaluate preliminary testing data, initiate NCMR and other quality related tasks as appropriate. Assist supervisor/manager in maintaining the current laboratory and QC/QA activities. Contact point for instrumentation issues and providing training and troubleshooting support to the laboratory on new or existing instrumentation. Monitor and ensure compliance of all laboratory equipment and associated systems and provide training to technicians as required. Prepare, review & approve laboratory documentation related to laboratory instrumentation and systems (e.g. SOPs, validation protocols, reports etc.) Provide support to laboratory investigations involving laboratory systems including NCMR and deviation Work with cross functional teams on new product transfer, qualification, validation, etc. Reviews, enters, and maintains stability data for developmental, clinical, and commercial products. Transfers analytical methods and qualification as applicable. Prepares and maintains QC/QA documentation, including protocols, reports, and test methods. Procures reference materials for contract analytical laboratories. Maintains and updates department documents required for regulatory compliance and assures testing requirements adherence to latest regulatory standards. Engage in managing the documentation Change Control Process including receiving / generating, identifying, distributing, tracking, and publishing Change Requests and Orders as applicable. Engage in filing, identification, archiving, storage, recovery and destruction of QC/QA Documentation and Records as needed. Review & Release of WIP Materials and Finished Goods for GMP this includes review of quality records for: Good Documentation Practices/Data Integrity Completeness of records Accuracy of records Lot/part/description accuracy Materials and Finished Goods included, but not limited to:
Required
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $36.00 - Maximum $48.30, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline: This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
The Quality Inspector role is to support manufacturing quality. Responsible for timely and effective GMP review of production records in order to maintain a continuous flow of records, and to manage and control materials used for the product realization including nonconforming materials. Responsible for Lot release testing.
Job Description
- Manufacturing site Policies and Procedures
- ISO 13485 QMS, 21 CFR 820 QSR
- Relevant global quality systems.
- Wafers
- HPC
- Preparation, and performing a variety of routine and QC/QA tasks following cGMP regulations
- Work collaboratively with required functions as part of a cross functional team to investigate customer complaints and address them in a timely manner.
- Work collaboratively with cross functional teams as relevant and ensure that Change controls, deviations/investigations, CAPAs are initiated and executed as applicable in a timely manner.
Required
- Knowledge of GMP (21 CFR Part 820, and ISO 13485)
- Hands-on knowledge of computer applications including use of the Internet, Word and Excel applications and presentation software such as Power Point
- Sound knowledge of cGMP and experience in a regulated industry
- Strong verbal and written communication skills
- Excellent organizational skills along with strong attention to detail
- HS degree is preferable or equivalent 2-3 years of experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing) with Quality Assurance role
- Experience with developing/documenting procedures/work instructions
- Familiar with a variety of the field's concepts, practices, and procedures
- Working knowledge of computerized quality systems (i.e. QMS, LIMS) is a plus
- Demonstrated change management experience, guiding the organization to the desired state
- Experience with Electronic Systems for handling complaints, investigations, CAPAs, Calibrations, Electronic Batch records, control of documents etc.
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.
Minimum $36.00 - Maximum $48.30, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
Application Deadline: This will be posted for a minimum of 5 business days.
Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer:
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.