SHARP STERILE MANUFACTURING LLC Jobs in United States

Perform visual inspection of the manufactured drug product through the packaging process including visual inspection in compliance with company policies / procedures, Food and Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations. · ...

Perform all production operations in the areas assigned within the facility. · ...

· Position Summary · Perform all production operations in the areas assigned within the facility.  Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities.  · Duties and Responsibilities · Operate glass washers and a ...

The Director of Manufacturing balances the urgency of daily shift operations with the pursuit of long-term goals while ensuring the highest standards · of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff mem ...

The QA Compliance Specialist II assists with compliance and quality activities at SSM. · Implementing cGMP and regulatory requirements at SSM. · Maintaining Quality Culture at SSM. · Provide indirect oversight of cGMP operations at SSM. · Work collaboratively within QMS to suppor ...

The Project Management Supervisor is tasked with establishing, maintaining, and enhancing the relationship between BSM and external clients. · Masters' Degree or equivalent work experience requiredPMP Certification preferredOne (1) to three (3) years previous project management e ...

The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignmen ...

The Senior Process Engineering Manager leads and oversees process engineering support for aseptic fill-finish and associated manufacturing operations at Sharp Sterile. · ...

· Position Summary · The Staff Accountant is responsible for a variety of accounting activities to support operations and ensure compliance with generally accepted accounting principles. · Duties and Responsibilities · Processing accounts payable to include invoice data entry an ...

Maintain quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements. · ...

The Maintenance Technician is responsible for the repairs and maintenance of the facility and equipment. ...

The Controller oversees financial operations including accounting transactional activities, financial analysis and reporting in accordance with IFRS to support strategic management decision making. · Manage financial operations and reporting relationship with parent company · Pre ...

The Project Manager is tasked with establishing, maintaining and enhancing the relationship between BSM and external clients. · Exhibit a quality mindset and a willingness to develop · Demonstrated knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requ ...

The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. · ...

The Project Manager facilitates all non-client site projects ensuring they are completed on time within budget and meet quality standards while coordinating with cross-functional teams. · Three to five years of experience in project management within the capital project and conti ...

The Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. · Five ...

The Senior Operations Engineering Manager is responsible for the technical ownership setup and consistent mechanical operation of all primary production equipment within our sterile fill-finish manufacturing facility. · This role leads a team of operations and equipment engineers ...

The Manufacturing Investigation Manager is responsible for leading and overseeing investigations associated with manufacturing deviations, · batch discrepancies, · equipment failures, · environmental events, · OOT issues, · and other GMP-related incidents.Duties include investiga ...

The QA Compliance Specialist I is responsible for assisting with compliance and quality activities at BSM. The role involves implementing cGMP and regulatory requirements. · Provide indirect oversight of cGMP operations at BSM · Work collaboratively within BSM's Quality Managemen ...

The Sterility Assurance Manager ensures sterility the leads contamination control program, aseptic processing simulation (media fill) program, · Oversee the Media Fill Program · Plan and design aseptic process simulations aligning with regulatory expectations, including frequency ...