Internship Third Party Audit Jobs in Rochester, NY

Responsibilities:

• The Aseptic Product Quality Manager acts as a quality SME for aseptic manufacturing within the External Product Quality Assurance Eye Care Global Team.

• Supporting aseptic events within the Eye Care Quality Assurance Third Party Manufactures (TPM) team by providing hands-on assessments and investigation support.

• Drive implementation and aseptic best practices at TPM based on standards and technological advancements.

• Work effectively with TPM by promoting improvements that proactively identify, quantify, prioritize, and mitigate aseptic risks.

• Global Quality Manager will also establish collaborative relationships with internal sites, aseptic global team, and cross functional teams.

• Maintains the primary quality lead with management oversight for project activities and the team members to achieve on-time quality deliverables, high customer value, and profitable results.

• Primary driver for the quality and compliance aspects of product transfers and organization optimization.

• Provides Eye Care Quality Assurance Third Party Manufactures (TPM) team support for investigation for aseptic events by providing hands-on assessments and investigation support.

• Drives implementation and aseptic best practices at TPM based on standards and technological advancements.

• Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.

• Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to management.

• Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.

• Helps facilitate resolution in cases where they are not.

• Establishes and maintains relationships and open communication with Third Party Manufacturers, plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.

• Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide with the agreed service.

• Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.

• Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable.

• Provides support for quality audits, initial site approvals and due diligence activities.

• Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.

• Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to domestic and International plants for further packaging and/or testing.

• Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events).

• Supports the management of exception documents and Corrective and Preventive Actions.

• Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.

• Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.

Qualifications:

• Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.

• 7+ years of total combined experience. At least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development or Consulting.

• Knowledge and comprehensive understanding of aseptic manufacturing and some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).

• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities