- As Quality Manager within our Operating Unit(s) you will lead the control and release oprations carried out within the Operating Unit. Duties will include but are not limited to:
- Actively participate in the harmonization of practices within your unit and on site
- Coordinate the sharing and harmonization of practices in the OU
- Ensure the preparation and participation of the OU's Quality teams in customer and regulatory audits on the OU
- Perform internal and/or GMP audits
- Write or approve procedures and instructions necessary for UO Quality
- Ensure realistic and harmonized application of OU procedures
- Validate the OU's means of production and control
- Approve changes made to the OU and processed in CCM
- Ensure that inspection and self-control ranges are managed to reflect customer or regulatory requirements
- Guarantee the release of finished products in accordance with customer specifications, DMF and specifications
- Ensure the availability of information needed for periodic Product reviews
- Ensure the effectiveness and relevance of the handling of internal deviations and non-conformities
- Ensure the analysis and handling of customer complaints
- Ensure that information related to the Quality of purchased or subcontracted products is effectively transmitted to Supplier QA
- Establish and communicate dashboards and annual reports on the performance of the products and services within its scope
- Ensure the establishment of Quality Improvement Plans (product, process, systems)
- Ensuring that best practices are shared between units
- Within its scope, ensure the identification, implementation and effectiveness of preventive and corrective actions resulting from deviations, non-conformities, complaints, audits, product reviews, progress projects
- Guarantee the representation of your business within a customer or internal project team
- Contribute to the industrialization of new products resulting from DRE projects and their transfer to the OU
- Lead the team adhering to all safety, GmP, ISO, FDA and other regulatory standards.
- Develop, coach and lead the quality team enhancing skills.
- Bachelor's degree in Life Sciences, Chemical or Plastic Engineering, or equivalent experience.
- 5 years prior experience managing a Quality Team and Quality function directly responsible for manufacturing output in line with Manufacturing requirements, Quality standards, ISO, GmP,
- At least 2 years of experience working in a manufacturing Clean Room Environment
- 2 years' experience in the product support or Quality Engineering in the realm of molding and assembly of high precision plastic components.
- Pharmaceutical or Medical Device industries experience a plus.
- Strong industry knowledge of dispensing business with strong compliance and cGMP skills.
- Knowledge of Product failure/complaint investigations practices (Ex. RCA, QRQC)
- Knowledge of statistical analysis techniques
- Knowledge of ISO, CFR 21 regulations and GMPs.
- Independent self-starter with excellent verbal and written communication skills.
- Proficient with Microsoft Office (Excel, PowerPoint, Outlook) and MS Project.
- Curiosity, initiative, self-motivated
- An exciting, diverse and value based working environment.
- Extensive Product training as well as an Award-winning corporate university offering personal development and training opportunities.
- Competitive base salary
- An opportunity to contribute to the communities where we reside.
- Innovative benefits plan which includes: 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more
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Quality Manager, Operating Unit - Congers, United States - AptarGroup
Description
Quality ManagerImproving Health through Science and Technology At Aptar Pharma, we specialize in Drug Delivery offering Innovative Devices, Services and Solutions focused on the Patient Experience. Aptar Pharma is part of Aptar Group, a global leader of dispensing systems for the packaging industry. Aptar Pharma has been setting the standard in drug delivery for decades providing health technology solutions and services enabling effective patient treatment. Be Aptar
What You Will Do at Aptar Pharma
As Quality Manager within our Operating Unit(s) you will lead the control and release oprations carried out within the Operating Unit. Duties will include but are not limited to:
Aptar Pharma offers a competitive total rewards package including base salary or base hourly rate determined by many factors including the role, experience, knowledge, skill set and location. For those in eligible roles, discretionary incentive compensation which may be awarded in recognition of individual achievements and contributions. The typical annual base pay range for the position of Quality Manager to the specific work location of: New York City metropolitan region is USD $95,000 to $120,000 per year . Additional details about total compensation and benefits will be provided during the hiring process.
BE YOU, BE APTAR
Aptar is an Equal Employment Opportunity (EEO) employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief It is the policy of the Company to provide equal employment opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Aptar Pharma, NA
250 Route 303 North
Congers, NY 10920
Improving Health through Science and Technology
