Savi Ehs Careers Jobs in Usa
495 positions found — Page 24
General Description:
Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.
Essential Functions of the job:
- Lead the QC Biochemistry GMP laboratory through late phase activities.
- Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and quality standards.
- Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
- Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.
- Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.
- Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.
- Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.
- Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
- Implementation of effective corrective actions and preventive actions (CAPAs).
- Participate in internal and external GMP audits where possible.
- Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
- Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
- Manage, motivate, coach and mentor direct reports.
- Undertake any other duties as required.
Core Competencies, Knowledge, and Skill Requirements:
- Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).
- Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.
- Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.
- Knowledgeable with USP/EP and cGMP/EU GMP regulations.
- Direct experience in a GMP quality control lab is a must.
- Familiar with instrument and equipment validation.
- Expert knowledge of quality control principles, practices, and standards for the biopharmaceutical industry.
- Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
- Credible and confident communicator (written and verbal) at all levels.
- Strong analytical and problem-solving ability.
- Excellent project management skills.
- Hands-on approach, with a ‘can do’ attitude.
- Ability to prioritize, demonstrating good time management skills.
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
- Self-motivated, with the ability to work proactively using own initiative.
- Committed to learning and development.
Supervisory Responsibilities:
- Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.
- Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.
- Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.
- Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
- Manage, motivate, coach and mentor direct reports.
CNC Machine Shop experience (hands on and managing people) The Manager is looking for someone that knows the ins and outs of a machine shop.
POSITION SUMMARY:
The Machine Shop Supervisor will be responsible of day-to-day operations of the machining department to meet safety, quality, delivery, cost targets and all sustainment/improvement related action and activities. This role will be responsible of managing people, schedules, workflows, equipment, and continuous improvement initiatives (including client Lean System practices) while ensuring compliance with company standards and applicable regulations.
SCOPE OF WORK:
• Oversee daily machining operations (CNC and manual) across multiple machines and cells.
• Plan, prioritize, and assign work orders to meet on-time delivery and productivity goals.
• Ensure adherence to safety, environmental (EHS), and quality standards such as AS9100.
• Manage a team of machinists, operators, and handle staffing, training, and performance.
• Maintain process control: setups, tool management, and program control.
• Coordinate preventive maintenance and escalate equipment downtime with Maintenance.
• Drive continuous improvement using client Lean System (PLS) tools: 5S, standard work, visual management, kaizen.
• Monitor production metrics (OEE, scrap, rework, first-pass yield, cycle time) and implement corrective actions.
• Control inventories (WIP, raw material, tooling, consumables).
• Collaborate with Quality, Engineering, Supply Chain, and Safety to resolve issues and improve processes.
• Support cost reduction through waste elimination, optimized setups and programs, and tooling/process improvements.
• Enforce documentation control: routings, work instructions, drawings, programs, and change management.
• Consistent exercise of independent judgment and discretion in matters of significance
• Ability to plan, set priorities for the team and direct technical efforts to meet business objectives
• Other responsibilities as assigned
• Regular, consistent, and punctual attendance is required. May need to work nights and weekends, variable schedule(s) and additional hours as necessary
• Ability to explain a range of complex technical information
• Effective interpersonal, verbal, and written communication skills to drive tasks to completion
Are you an experienced Grind Operator with strong centreless grinding capability in a precision manufacturing environment? Do you want to work on safety critical components where quality and consistency are essential? Are you looking for long term stability and development in a growing aerospace business? If so, this opportunity may be the right next step for you.
This business is a leading aerospace fastener manufacturer supporting highly demanding applications. With fully vertically integrated operations including forging, heat treatment, machining, centreless grinding, thread rolling, NDT and mechanical testing, the operation is built around quality, accountability and continuous improvement.
The purpose of this role is to produce high quality aerospace components using centreless grinding processes, ensuring all parts meet drawing and specification requirements while maintaining safe working practices.
As the Grind Operator your responsibilities will include
- Producing parts using centreless grinding methods that meet drawing and specification requirements
- Verifying machine settings prior to operation
- Following customer and internal work instructions accurately
- Performing basic machine maintenance in line with PM schedules
- Troubleshooting tooling or equipment issues and maintaining shop floor standards
As the Grind Operator you will bring
- Ability to read and interpret engineering drawings
- Strong shop maths skills and basic computer literacy
- Three to five years or more of centreless grinding experience
- Experience using inspection equipment including micrometers and calipers
- Background working with manual OM grinders, camout machines or CNC grinders
You will join a business with a positive and supportive culture where people are encouraged to develop and grow. Competitive pay is offered alongside clear long term career opportunity, making this an environment where commitment and skill are genuinely valued.
This role requires the ability to stand for extended periods and lift up to 30 lbs in line with EHS policies, with flexibility to work overtime when required.
All successful applicants will be contacted within two working days.
Job Description:
- Operates production equipment.
- Constructs, maintains, and tests mechanical systems and components/assemblies.
- Candidate would have manufacturing and/ or small hand tools experience preferably.
Responsibilities:
- Follows blueprints, guidelines, and/or diagrams to ensure product specifications and tolerance levels are met.
- Performs troubleshooting, calibrations or modifications of hardware, fixtures and software.
- Uses measuring and diagnostic tools to test and modify systems and components/assemblies.
- Maintains records of production and reports any issues while following standard procedures.
- Interprets data and accurately records time changes, test data, parts usage, etc.
- Utilizes mechanical or optical equipment, including computers and lasers.
- Provides technical solutions to engineering.
- Ensures systems and components/assemblies meet established specifications.
- Reworks and repairs various mechanical and electromechanical systems and components/ assemblies as needed.
- May assist engineering with the design of components and prototypes.
- May be trained/certified in multiple skills.
- May train and mentor new technicians.
- Exhibits RTX Leadership Behaviours and Values.
- Supports and follows all rules/guidelines/standards set by EHS, Quality and CI functions as set by assigned leader and position.
Requirements:
- Perform other duties as assigned including working extended shifts/overtime as required by the business.
- Education:
- HS Diploma
POSITION SUMMARY:
The Production Shift Manager is responsible for coordination and supervision of the production process on the assigned shift to ensure production targets are met timely and efficiently.
ESSENTIAL FUNCTIONS:
- Manages and coordinates all activities of the production team on an assigned shift.
- Cooperates and with other departments to ensure effective plant operations and problem-solving.
- Communicates with supervisors and team members to troubleshoot and resolve issues.
- Leads plant initiatives, corrective actions and effective decision-making related to plant operation.
- Ensures company policies and safety procedures are being followed in the plant.
- Ensures team members have the tools and necessary training to perform and meet departmental goals.
- Recommends and implements measures to improve methods, equipment, performance, product quality, and efficiency through daily information sharing and reporting.
- Communicates, coaches, counsels, and trains supervisors and team members on standardized work practices, 5S, safety, quality and team building to meet company production goals and expectations.
- Ensures performance issues, conflicts, and other disciplinary issues are addressed and resolved timely and effectively. Initiates disciplinary action through communication with the Plant department supervisors, managers, and HR.
- Participates, facilitates, and oversees evaluations, CFTs, committees, task forces.
- Follows and ensures Lean and continuous improvement methodology.
- Supports EHS objectives.
- Other duties as assigned.
EDUCATION AND EXPERINCE:
- Auto-Manufacturing industry experience strongly preferred.
- Minimum 5 years of experience in a managerial or supervisory role.
- Strong organization and time management skills.
- Excellent communication skills both written and verbal.
- Computer skills to include Word, PowerPoint, Excel.
SUPERVISORY RESPONSIBILITY:
Directly oversees plant employees to include hourly and salaried team members on the assigned shift.
Essential Job Functions:
Develops, evaluates, and improves manufacturing processes while maintaining compliance to design specifications.
Programming of equipment, creation of CNC code, and tool path simulation.
Primary contact for design engineering or program management on manufacturing processes.
Creates and maintains manufacturing methods, Bill of Materials, and labor standards in ERP system.
Participates in activities related to C.I. and cost reductions/process improvements.
Design, construction, and validation of tooling, fixtures, gages, and equipment.
Workflow / cell design with a focus on waste reduction and process improvement.
Analysis of manufacturing variances to help identify key areas in need of improvement.
Troubleshoot and solve manufacturing problems in a machining environment.
Support Supply Chain and Quality with supplier development activities as needed.
Mentor/guide lower level manufacturing engineers.
Support customer complaints and concerns.
Provide support for Lean manufacturing and continuous improvement initiatives, companywide.
Other duties, reporting, special assignments, or projects as needed and assigned.
Must remain current with, and complete all required training as assigned.
Must adhere to Company Corporate EHS Policy and department, occupation, and task specific safety protocols, including but not limited to Personal Protective Equipment (PPE) requirements.
Qualifications:
5-10 years manufacturing engineering experience.
Minimum 5 years CAD and CAM software experience required. Mastercam preferred.
AutoCAD Inventor 3D modelling or similar software required.
Vericut experience preferred.
Ability to read and interpret complex 2D blueprints and 3D models required.
Working knowledge of GD&T required.
Experience with tooling selection and fixture design required.
Knowledge of both manual and CNC machining equipment, specifically multi-axis (5+) programming experience.
Hands on troubleshooting & problem solving including statistical analysis.
Ability to implement change and train employees in a production floor environment.
Excellent technical, written, and oral communication skills.
Working knowledge of Microsoft products.
Must submit to and satisfactorily pass any pre-employment screening required for employment with the Company.
Must take medical exams required by law, in conjunction with occupation specific activities, the physical work environment, and ongoing industrial hygiene sampling results.
Depending on assignment, may be required to use stairs, remain upright and/or seated for prolonged timeframes, intermittently reposition the body per various tasks performed, and use various tools and work-related supplies.
May be required to perform manual lifting activities, not to exceed a 40lb lift performed by one individual.
Education:
Four-year degree in engineering preferred, but not required (mechanical, aerospace, or manufacturing preferred)
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
Job Description Summary
The Human Resources Plant Manager at our Hobart, NY facility provides leadership and direction in the areas of employee engagement, organizational design, training, benefits, compensation and employee/labor relations to ensure the HR strategy positively impacts the site and the organization. This is a site leadership role that collaborates with other site leadership members and the corporate Human Resources team to drive strategic and tactical Human Resources programs, policies, and initiatives to support the business.
Must be able to assess, identify or develop, implement and monitor policies and programs related to staffing, recruiting, compensation, training, benefits, and employee relations consistent with division strategic and tactical plans.
Other highly desirable experiences include practicing in a highly regulated environment, experience with Worker's Compensation/Occupational Health and promoting cultural change and performance excellence manufacturing initiatives.
Creates departmental objectives, recommends operational policies, and proposes annual budgets. Develops and administers budgets, schedules, and performance standards. Has full management responsibility over staff, including performance appraisals, salary, etc. Leads change management initiatives and coordinates with corporate communications as needed.
SUMMARY OF POSITION:
The Human Resources Plant Manager at our Hobart, NY facility provides leadership and direction in the areas of employee engagement, organizational design, training, benefits, compensation and employee/labor relations to ensure the HR strategy positively impacts the site and the organization. This is a site leadership role that collaborates with other site leadership members and the corporate Human Resources team to drive strategic and tactical Human Resources programs, policies, and initiatives to support the business.
Must be able to assess, identify or develop, implement and monitor policies and programs related to staffing, recruiting, compensation, training, benefits, and employee relations consistent with division strategic and tactical plans.
Other highly desirable experiences include practicing in a highly regulated environment, experience with Worker's Compensation/Occupational Health and promoting cultural change and performance excellence manufacturing initiatives.
Creates departmental objectives, recommends operational policies, and proposes annual budgets. Develops and administers budgets, schedules, and performance standards. Has full management responsibility over staff, including performance appraisals, salary, etc. Leads change management initiatives and coordinates with corporate communications as needed.
ESSENTIAL FUNCTIONS:
- Develops the Human Resource strategic direction for the plant in collaboration with the Site Leadership Team.
- Ensures the adherence to and consistent application of established policies, programs, and procedures that apply to all employees of the site.
- Engages in a regular review of Plant and Company policies and procedures, and collaborates with Site Leadership and Corporate HR to revise and change policies and procedures.
- Ensures compliance in all HR-related regulatory areas of responsibility (EEO, OFCCP, OSHA, FMLA, ADA, etc.).
- Works effectively with Corporate HR and Legal counsel to resolve issues related to labor/employee relations, pending legal cases and arbitrations, and compliance activity.
- Talent Management: Provides leadership and direction in the areas of recruitment, retention, and succession planning for both the hourly and salaried workforce.
- Provides guidance on and ensures compliance with company compensation plan.
- Implements and maintains affirmative action program and records to conform with EEO Regulations.
- Provides leadership and direction in the areas of employee engagement, organizational design, training, benefits, medical, compensation, and employee/labor relations.
- Partners with Site Leadership to create and maintain professional development and training programs that improve results and increase the skill level of the workforce, while supporting site and organization objectives.
- Partners with the Site Director, EHS Department, and Site Leadership to create and maintain programs that ensure the highest level of safety at the Plant.
- Effectively manages multiple projects and provides guidance to subordinate managers on priorities, strategy, and resources.
- Effectively administers performance management and compensation planning programs at the site, particularly the annual review process for salaried employees, and ensures a high quality and efficient process.
- Develops appropriate strategies to effectively communicate information to both internal (employee) and external (community) groups regarding relevant information and updates about the site.
- Provides leadership and developmental guidelines for direct reports and indirect reports as it relates to their professional growth and the needs of the department and business.
- Guide managers on performance and behavior issues including performance improvement plans and corrective action.
- Coach employees and management through complex and difficult situations.
- Serve as leader or active member on various committees or project teams within and outside the HR organization, as needed.
MINIMUM REQUIREMENTS:
Education:
Bachelor's Degree in Human Resources or related field. Equivalent work experience will be considered. Advanced Degree attainment along with HR certification are preferred but not required.
Experience:
A minimum of 8 years of related experience, within the HR function is required, with particular emphasis within the Generalist/Business Partner area.
Preferred Skills/Qualifications:
- Working knowledge of the Pharmaceutical or Life Sciences industry highly preferred.
- Experience supporting a complex manufacturing environment preferred.
Skills/Competencies:
- Strong analytical and problem solving skills with the ability to work through complex and ambiguous situations
- Able to work collaboratively in a team environment
- Able to make decisions independently with minimal supervision
- Strong sense of urgency, initiative, and drive for results
- Able to work in a fast pace environment
- Able to multi-task and manage workload effectively
- Able to demonstrate confidence in data driven decision making and work with all levels of leadership
- Strong communication and influencing skills
- Able to lead cross functional teams through projects
- Proficient in Microsoft Office and HR related systems
ORGANIZATIONAL RELATIONSHIPS/SCOPE: This position reports directly to the Sr. Director Human Resources. This position has direct reports.
WORKING CONDITIONS: Plant environment requiring ability to maintain face-to-face contact with employees throughout the campus. Willingness to work in plant environment that requires all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
The expected base pay range for this position is $150,000 – $185,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company’s discretion.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Description
Accountable for developing, improving, and supporting all production processes associated with the launch, manufacture, and test of products in an assigned value stream or product line.
Often directs, guides, or mentors activities of Level I Process Engineers, prioritizing workload based upon needs of production floor.
Come join our family and be part of a team of individuals who enjoy excellent health and retirement benefits, competitive pay, a comfortable work environment, and co-workers who enjoy working and learning together as a team. Apply today!!
Essential Job Functions:
Develops, evaluates, and improves manufacturing processes while maintaining compliance to design specifications.
Programming of equipment, creation of CNC code, and tool path simulation.
Primary contact for design engineering or program management on manufacturing processes.
Creates and maintains manufacturing methods, Bill of Materials, and labor standards in ERP system.
Participates in activities related to C.I. and cost reductions/process improvements.
Design, construction, and validation of tooling, fixtures, gages, and equipment.
Workflow / cell design with a focus on waste reduction and process improvement.
Analysis of manufacturing variances to help identify key areas in need of improvement.
Troubleshoot and solve manufacturing problems in a machining environment.
Support Supply Chain and Quality with supplier development activities as needed.
Mentor/guide lower level manufacturing engineers.
Support customer complaints and concerns.
Provide support for Lean manufacturing and continuous improvement initiatives, companywide.
Other duties, reporting, special assignments, or projects as needed and assigned.
Must remain current with, and complete all required training as assigned.
Must adhere to Company Corporate EHS Policy and department, occupation, and task specific safety protocols, including but not limited to Personal Protective Equipment (PPE) requirements.
Qualifications:
5-10 years manufacturing engineering experience.
Minimum 5 years CAD and CAM software experience required. Mastercam preferred.
AutoCAD Inventor 3D modelling or similar software required.
Vericut experience preferred.
Ability to read and interpret complex 2D blueprints and 3D models required.
Working knowledge of GD&T required.
Experience with tooling selection and fixture design required.
Knowledge of both manual and CNC machining equipment, specifically multi-axis (5+) programming experience.
Hands on troubleshooting & problem solving including statistical analysis.
Ability to implement change and train employees in a production floor environment.
Excellent technical, written, and oral communication skills.
Working knowledge of Microsoft products.
Must submit to and satisfactorily pass any pre-employment screening required for employment with the Company.
Must take medical exams required by law, in conjunction with occupation specific activities, the physical work environment, and ongoing industrial hygiene sampling results.
Depending on assignment, may be required to use stairs, remain upright and/or seated for prolonged timeframes, intermittently reposition the body per various tasks performed, and use various tools and work-related supplies.
May be required to perform manual lifting activities, not to exceed a 40lb lift performed by one individual.
Education:
Four-year degree in engineering preferred, but not required (mechanical, aerospace, or manufacturing preferred)
MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)
Location – Wilson, NC
Aztec Technologies is an engineering and consulting firm providing expertise in the
pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation
are part of Trinity Consultants Company.
Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting
services with 1500+ engineers worldwide.
Aztec Technologies provides solutions for Manufacturing Applications:
• Process and Facility Automation
• Project Management
• MES
• Data Analytics
With offices across 3 continents, consulting firm with over 20 years of experience within the
biopharmaceutical and pharmaceuticals industries.
The successful candidate will work with a group of engineers involved in the design, automation,
commissioning and start-up of various processes, systems, and facilities. A combination of
strong technical aptitude, automation engineering skills and technical writing are the desired skill
set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences
space that will enhance professional opportunities!
Candidates need to be local or willing to relocate to the areas of operation where we have open
opportunities for immediate hire in the Wilson, NC area:
Key Responsibilities:
- Own MES configuration management for PAS-X, including:
- Manufacturing Batch Records (MBRs)
- Material management
- Equipment and timer management
- Label management
- Lead MES design, configuration, testing, and troubleshooting
- Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
- Support MBR migration from a legacy site
- Ensure alignment with site and global MES standards
- Support risk assessments and GMP compliance activities
- Provide hands-on troubleshooting and technical support during execution
- Develop and maintain MES technical documentation
- Collaborate closely with IT, Manufacturing, Quality, and Engineering teams
Required Qualifications
- 8+ years experience in pharmaceutical or biopharmaceutical manufacturing environments
- Strong hands-on experience with MES platforms, preferably Werum PAS-X
- Proven experience with MBR design and execution
- Solid understanding of GMP manufacturing processes
- Experience integrating MES with DCS (DeltaV) and enterprise systems
- Strong analytical, troubleshooting, and problem-solving skills
- Bachelor’s degree in Engineering, IT, Science, or related discipline
Preferred / Nice-to-Have Skills
- Programming experience: .NET, SQL / PL-SQL, Java
- Experience with OPC servers/clients
- Knowledge of 21 CFR Part 11 and EU GMP Annex 11
- Process knowledge across:
- Upstream
- Downstream
- Bioprocess support functions
- Ability to communicate effectively with both technical and non-technical stakeholders
Ideal Candidate Profile:
- Senior-level PAS-X MES SME
- Strong on-site presence and ownership mindset
- Comfortable operating as Owner’s Rep, not a junior configurator
- Deep pharma/biotech automation background
- Able to bridge Manufacturing, IT, Automation, and Quality
Quality Assurance Manager
ATTRACTIVE SKILLS / EXPERIENCES:
- Bachelor's Degree in Chemistry, Biology, Engineering or related field (required)
- Experience (3+ years) in a leading/managing a Quality Department/Group
- Demonstrated knowledge of ISO standards (9001; 14001; 15378) along with cGMP
- Experience and knowledge with MS Office applications (especially MS Excel)
- Experience and knowledge with SAP and electronic QMS systems
- Demonstrated communication skills (written / oral) including the ability to read/speak English
- Ability and willingness to work in office and in a production floor setting with moderate noise
- Ability and willingness to work in fast-paced, matrix structured organization
- Willing to work traditional business hours (8am to 5pm) during weekdays (M-F) with the flexibility to accommodate supporting the 24/7 shift schedule
SUMMARY / RESPONSIBILITIES:
- Assist in developing department budget and investment plan(s) according to strategic goals
- Cultivate employee talent through training and coaching measures, while also conducting employee performance reviews
- Support the development and updating of Quality Assurance programs, policies, processes, procedures and controls
- Review, analyze and report on quality discrepancies related to SCHOTT products, while developing disposition and corrective actions for product discrepancies
- Manage the review of batch records and avoid impacting shipment dates
- Manage Department Training Coordinator activities and projects
- Manage document control activities to include, releasing, archiving, tracking and reporting of the document review process for controlled documents
- Lead and support the implementation of Systems and Compliance Improvements including site compliance, along with data integrity requirements
- Measure and analyze Quality System trends
- Oversee the internal audit function to ensure ongoing compliance to the Quality Management System (QMS)
- Maintain the Archive Room and document retention requirements
- Write and revise Standard Operating Procedures (SOPs) and provide training, as required
- Manage the CAPA and Change-Control process to include, issuing, reviewing and approving steps
- Support all customer or registrar quality related audits and/or evaluations
- Utilize quality tools, including Compliant-PRO, etc., for information, tracking and reporting purposes, as required by the Pharm Business Unit
- Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventive and corrective actions in a timely manner as a result of customer complaints or customer audit findings
- Help promote and implement safety/EHS directives and maintain a clean and safe workspace
- Assure compliance with ISO certifications and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines