Sr. Quality Assurance Specialist
Apply NowCompany: Lupin Laboratories
Location: Somerset, NJ 08873
Description:
Overview
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women's health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Responsibilities
Role and Responsibilities
The Sr. QA Specialist, Change Control / CAPA is responsible for management of Change Control and CAPA systems at Lupin Somerset. The person in this role will provide review and oversight to all the Change Controls and CAPAs proposed for manufacturing, packaging and testing processes to ensure that the Changes Controls and CAPAs are performed in a timely and controlled manner in compliance with approved procedures to produce the desired outcomes
Responsibilities and Duties:
Qualifications
Minimum Education and Experience Requirements
Work Schedule
The regularly scheduled workweek is Monday through Friday and the hours are generally 8:00am - 5:00pm
Physical Requirements
The physical requirements of the position generally include: standing, walking, siting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 10 pounds occasionally. Generally, work is performed in an office environment.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran's status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin 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
Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women's health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.
Responsibilities
Role and Responsibilities
The Sr. QA Specialist, Change Control / CAPA is responsible for management of Change Control and CAPA systems at Lupin Somerset. The person in this role will provide review and oversight to all the Change Controls and CAPAs proposed for manufacturing, packaging and testing processes to ensure that the Changes Controls and CAPAs are performed in a timely and controlled manner in compliance with approved procedures to produce the desired outcomes
Responsibilities and Duties:
- Develop and implement policies and procedures for Change Control and CAPA systems consistent with FDA regulations and Corporate requirements
- Serves as Change Control coordinator to ensure that all change proposals have comprehensive rationale, impact assessment, and implementation plans and follow up actions documented. Ensures that all approved actions are implemented as per commitment.
- Convene weekly change control committee meetings to escalate level II changes for committee's review. Conduct / Review risk assessments where necessary.
- Collaborate with SMEs from various functional departments to ensure that changes are reviewed and approved, consistent with requirements of site / corporate SOPs.
- Ensure that Corrective and Preventive actions identified through investigation and audit processes are properly documented and implemented.
- Follow up with Change Control / CAPA owners to ensure timely implementation.
- Develop and monitor site metrics and reports for Change Controls and CAPAs. Report progress to site leadership periodically.
- Other duties as assigned by leadership
Qualifications
Minimum Education and Experience Requirements
- Minimum Bachelor Degree in a scientific or technical field; graduate degree desired
- 8+ years' of extensive experience in the pharmaceutical industry in Quality Assurance. Cross functional experience in Engineering, Technical Operations, Regulatory Affairs, Product development or Laboratory is a plus
- Working knowledge of FDA and applicable non-US regulations, guidance and industry standards pertaining to pharmaceutical drug manufacturing. Participation in FDA / customer audits is desirable
- Experience with Process / Method validation, Equipment / Facility Qualification and Regulatory requirements for product submissions is a big plus
- Thorough understanding of Cross-functional Quality Systems such as Deviations, Complaints, OOS is mandatory.
- Experience in using electronic Quality Management System, ERP system, MS Office applications. Experience with Trackwise is preferable.
- Excellent analytical, coordination and influential skills; Must be able to persuade cross functional teams to achieve results
Work Schedule
The regularly scheduled workweek is Monday through Friday and the hours are generally 8:00am - 5:00pm
Physical Requirements
The physical requirements of the position generally include: standing, walking, siting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 10 pounds occasionally. Generally, work is performed in an office environment.
Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran's status, or any other classification as required by applicable law.
Physical Requirements
The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.
Search Firm Representatives Please Read Carefully
Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin 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