Current jobs related to Contract Manufacturing Quality Associate - New Brunswick NJ United States - Sun Pharma (Taro Pharma)
-
Manufacturing Quality Assurance Associate
4 weeks ago
New Hanover County Airport, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
New Hanover County Airport, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Specialist
1 month ago
, NC, United States Quality Chemical Laboratories Full timeManufacturing Quality Assurance AssociateQuality Chemical Laboratories (QCL) is seeking a highly skilled Manufacturing Quality Assurance Associate to join our team.About the Role:We are looking for a detail-oriented and organized individual to perform GMP reviews of manufacturing records and data, review and release manufacturing product batches, and assist...
-
New Kensington, Pennsylvania, United States Re:Build Manufacturing Full timeAbout Re:Build ManufacturingRe:Build Manufacturing is a pioneering industrial company that combines innovative technologies, operational excellence, and strategic partnerships to drive growth and innovation in the US manufacturing sector. Our mission is to revitalize the US manufacturing base by leveraging our expertise in operations management and...
-
New Kensington, Pennsylvania, United States Re:Build Manufacturing Full timeAbout Re:Build ManufacturingRe:Build Manufacturing is a family of industrial businesses that combines innovative enabling technologies, operational superiority, and strategic M&A to build America's next generation industrial company. Our goal is to help revitalize the U.S. manufacturing base over the coming decades, creating substantial opportunities for our...
-
New Kensington, Pennsylvania, United States Re:Build Manufacturing Full timeAbout Re:Build ManufacturingRe:Build Manufacturing is a family of industrial businesses that combines innovative enabling technologies, operational superiority, and strategic M&A to build America's next generation industrial company. Our goal is to help revitalize the U.S. manufacturing base over the coming decades, creating substantial opportunities for our...
-
New Kensington, Pennsylvania, United States Re:Build Manufacturing Full timeAbout Re:Build ManufacturingRe:Build Manufacturing is a pioneering industrial company that combines innovative technologies, operational excellence, and strategic partnerships to drive the next generation of American manufacturing. Our mission is to revitalize the U.S. manufacturing base, creating opportunities for our employees, customers, and...
-
New Kensington, Pennsylvania, United States Re:Build Manufacturing Full timeAbout the RoleWe are seeking a highly motivated and results-focused Business Development Director to join our team at Re:Build Manufacturing. As a key member of our commercial team, you will be responsible for identifying, pursuing, and securing new business opportunities across multiple industries, including Aero & Defense, Cleantech, Health, Industrial...
-
New Albany, Ohio, United States American Regent, Inc. Full timeJob Summary:The QA Contract Manufacturing Organization Specialist is a critical member of the Quality Assurance team at American Regent, Inc. This role is responsible for ensuring the quality of pharmaceutical products manufactured by third-party contract manufacturers.Key Responsibilities:Provide quality assurance review of batch records to ensure...
-
New Kensington, Pennsylvania, United States Re:Build Manufacturing Full timeAbout Re:Build ManufacturingRe:Build Manufacturing is a leading industrial company that combines innovative technologies, operational excellence, and strategic partnerships to drive growth and competitiveness in the US manufacturing sector. We leverage our expertise in operations management and technology to deliver high-performance solutions to our clients,...
-
Medical Manufacturing Associate
1 week ago
Groveton, NH, Coos County, NH; New Hampshire, United States Momentum Manufacturing Group LLC Full timeMomentum Manufacturing Group is a leading manufacturing partner to OEMs and product manufacturers across various markets. With a skilled workforce of over 800, 14 manufacturing facilities across the Northeast, more than 850,000 sq. ft. of manufacturing space, and a full suite of in-house metal manufacturing and value-added capabilities, we are an integral...
-
New Albany, Ohio, United States American Regent, Inc. Full timeJob SummaryThis role is part of the Quality Assurance team at American Regent, Inc. The QA Contract Manufacturing Organization Specialist is responsible for ensuring the quality of pharmaceutical products manufactured by third-party contractors. The Specialist will review batch records, ensure compliance with cGMPs and company SOPs, and collaborate with...
-
Quality Assurance Associate
2 weeks ago
New Brunswick, New Jersey, United States ProStaff Solutions Inc Full timeJob OpportunityWe are seeking a highly skilled Quality Assurance Associate to join our team at ProStaff Solutions Inc. This role is responsible for ensuring the quality and compliance of our manufacturing processes.Key ResponsibilitiesInvestigate and resolve manufacturing process deviationsEnsure compliance with cGMP regulations and company...
-
Quality - ExM Quality Analytical Manager
4 weeks ago
New Brunswick, United States Omni Inclusive Full timeSenior Manager Hybrid Role New Brunswick NJ Work Schedule: Mon - Fri, Business Hours Business Unit / Department External Manufacturing Quality Principle Objective of Position This role is a development opportunity for 12 months to gain experience on the analytical testing aspects associated with Drug Substance and Drug Product manufacturing, working in an...
-
Quality Assurance Inspector
1 week ago
new york city (bloomfield), United States Pearse Bertram+ Streamline Contract Manufacturing Full timePearse Bertram is the leading provider of distribution and contract manufacturing services for automation and process control solutions.We work hard and we play hard and we’re looking to add an experienced Quality Assurance Inspector to our Quality team to support our continued growth. The ideal candidate will have experience with Electrical, Hydraulic and...
-
Manufacturing Operations Director
4 weeks ago
Brunswick, Georgia, United States Manufacturing Company - Brunswick, GA Full timeJob OverviewWe are seeking an experienced and dynamic leader to oversee all aspects of our manufacturing company's operations in Brunswick, GA. As the General Manager, you will be responsible for ensuring efficient production, quality control, and overall business success.Key ResponsibilitiesLeadership and Team ManagementProvide strong leadership to the...
-
Manufacturing Operations Director
1 week ago
Brunswick, Georgia, United States Manufacturing Company - Brunswick, GA Full timeJob OverviewWe are seeking an experienced and dynamic leader to oversee all aspects of our manufacturing company's operations in Brunswick, GA. As the General Manager, you will be responsible for ensuring efficient production, quality control, and overall business success.Key Responsibilities:Leadership and Team Management:Provide strong leadership to the...
-
Final Quality Inspector
6 days ago
, OH, United States Hi-Tek Manufacturing Inc Full timeHi-Tek Manufacturing Inc. is seeking a skilled Final Quality Inspector to join our team. As a key member of our quality control team, you will be responsible for ensuring the highest level of workmanship in our manufacturing process.The ideal candidate will have a strong background in quality inspection and a passion for delivering exceptional results. You...
-
Quality Assurance Associate
4 weeks ago
, NC, United States Quality Chemical Laboratories Full timeQuality Assurance Associate - Report GenerationQuality Chemical Laboratories (QCL) is seeking a detail-oriented Quality Assurance Associate to join our team. As a QA Associate, you will be responsible for reviewing and approving reports generated from laboratory data, ensuring compliance with Good Manufacturing Practices (GMPs) and Standard Operating...
-
Contract Manufacturing Operations Manager
3 weeks ago
New Bedford, Massachusetts, United States Medtronic Full timeAbout the RoleWe are seeking a highly skilled and experienced Contract Manufacturing Operations Manager to join our team at Medtronic. As a key member of our Global Operations and Supply Chain organization, you will play a critical role in supporting the operational performance of our Contract Manufacturers.Key ResponsibilitiesLead performance management and...
Contract Manufacturing Quality Associate
5 months ago
Contract Manufacturing Associate
Job Summary
Support Quality activities at Contract Manufacturing Organizations (CMO) by providing timely and effective quality oversight. Accomplish quality objectives by planning and evaluating project activities. Support may include operations and validation.
Area of Responsibility
Review of manufacturing and packaging records
Review certificate of analysis and Certificate of compliance
Ensure the release packages are ready prior to batch disposition
Review of QMS records submitted by CMO and monitoring (e.g. change controls/deviations, quality agreements but not limited to)
Manage and oversee complaint, change control, and variation-filing modules for CMO activity.
Actively participate in day to day meetings
Participate in the qualification process and support assigned CMO aligned with the Sun Pharma Quality Management Systems and provide reports as required.
Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.
Implement and maintain Regional CMO data in the Global CMO database.
Ensure the Quality Assurance Agreements which are created and maintained according to Sun Pharma requirements, are regularly reviewed and followed.
Conduct review and approve batch release documentation.
Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
Manage and oversee complaint module for Ohm Site. Work Conditions:
Office Environment
Lab Environment
Manufacturing Environment
Environmental related to manufacturing/production environments:
Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
Odors: Unpleasant smells.
JOB DESCRIPTION
Gases: Examples include carbon monoxide and ozone.
Dust: Airborne particles of any kind, such as textile dust, wood, and silica. Physical Requirements:
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
Must be capable of bending and lifting, moving and/or carrying up to approximately 20 pounds.
Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes. Travel Estimate
Up to 10 % Education and Job Qualification
Minimum of a Bachelor’s degree in a scientific discipline; MS preferred.
Certified Quality Auditor (e.g. ASQ) certification preferred.
Expert skills related to investigations (e.g. Lean Six Sigma) Quality Agreements, and CMO management.
Ability to identify key priorities necessary for and be able to author/implement global policies and procedures.
Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools.
Strong knowledge of cGMP, QA/QC and regulatory compliance (US, EU and other regulatory requirements).
Strong interpersonal and communication, both written and verbal, skills.
Good negotiation and influencing skills.
Operational knowledge of pharmaceutical processing and packaging operations.
Task oriented team plan who is able to manage multiple complex priorities and work in a cross-cultural working environment.
The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR). Experience
Minimum of five (05) years of related experience in a cGMP environment, preferably in a project management capacity for pharmaceutical or biotechnology industries.
Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
EEO Notice:
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Taro. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral
