Site Quality Control Jobs

Must have excellent organizational, management, and people development skills.

Develops and manages budget, organizational structure and business requirements to accommodate business needs and assure meeting JSC metrics.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

The incumbent must have 9 years QA/QC experience in the pharmaceutical industry.

Strong knowledge in regulatory compliance, Quality Systems, pharmaceutical industry, pharmaceutical methods and procedures

Must use interpersonal and teamwork skills to build interdependent partnerships.

Experience in quality management and quality control processes; Wind Turbine Assembly experience preferred

Generates and presents periodic reports to the Nordex supplier management team.

Performs Quality Lead responsibilities in the Quality Lead’s absence.

Minimum of 3 years of mechanical/construction supervisory experience; Wind Farm mechanical construction experience preferred

WTG on-site assembly experience preferred

Analytical skills – must be able to reach conclusions and make recommendations based on collected data

Experience in quality management/quality control processes

Strong computer skills including knowledge of MS office applications (i.e.: Word, Excel, PowerPoint)

DEPARTMENT: Project Management (Site Management / Erection / I

Serves as a key member of the Wind Farm Site leadership team, and the on-site representative of the Quality Manager.

Prepares reports for the Site Manager and the Quality Manager summarizing the status of all quality issues and activities on site.

Monitors the project plan and rotation schedule to anticipate manning requirements and provide timely recommendations on staffing.

Might be designated as Management Representative and/or Head of Quality Make for the Site by the Operating Company.

Responsible for communicating business related issues or opportunities to next management level

15 or more years of related experience and/or training; or equivalent combination of education and experience

Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, manufacturing problems and quality systems indicators.

Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.

Organizes, plans, leads and manages quality related projects in alignment with company goals Facilitates the development and training of immediate staff.

Experience applying time management skills to planning and prioritizing a heavy workload.

Perform other responsibilities and duties as assigned.

Three or more years of experience in Distribution Line Construction, Planning, or Civil Construction.

Experience with safe work practices, basic electrical theory, construction/maintenance standards (i.e., GO95 and GO128), and the electric distribution system.

Experience working both independently and in a team environment to meet shared goals and objectives.

Experience interfacing and collaborating with internal and external customers.

Ability to conduct Audits and First Article Inspections per a defined Quality Management System

Ability to effectively communicate with management, supervisors, and peers to resolve issues

Inspect for acceptance, all types and series of hardware to determine that build, rework, modification and repairs conform to contractual/drawing requirements.

Meet necessary certifications as required.

Experience using calibrated inspection measurement tools such as micrometers, calipers, microscope, and rulers

Experience with drawing and blueprint reading and interpretation

BS in Construction Management or Engineering or equivalent work experience.

Experience in personnel management, and staffing and scheduling.

Experience in contractor, consultant and vendor management.

Provide training of personnel to ensure awareness of quality procedures and specific responsibilities in the QA/QC process.

7+ years’ experience in quality control & quality assurance (QA/QC) programs for data centers or mission critical construction projects.

Experience with Design-Build and Design-Bid-Build construction programs.

Responsible for end-to-end Quality within the site, including FUSE qualification/validation, materials management, batch record reviews, change control, and deviations

Collaborate with internal partners to enable compliant and successful manufacturing (e.g. technology transfers, validation, testing, and lifecycle management)

Direct experience hosting Health Authority inspections

Prior experience in the manufacture of cell and gene therapy products

Provide strategic direction and operational leadership for the site Quality function at CRISPR’s internal manufacturing facility

Chair the site Quality Review Board and establish quality metrics to demonstrate adherence to GMP regulations and CRISPR procedures

Accountable for timely notification and effective management of internal and Client-related changes

Comprehensive knowledge of global GMP regulatory requirements for cell & gene therapy products

Experience with facility commissioning and qualification

Provides compliance and strategic guidance during the design and qualification of the plant expansions.

Manages effectively the site’s GMP training program. Champions initiatives for continued learning and development.

Develops and manages departmental goals and corresponding budget in alignment with corporate vision and goals

Knowledge and understanding of pharmaceutical quality management systems and drug manufacturing.

Skilled in project management and ability to problem solve utilizing a collaborative approach to resolutions.

Regulatory knowledge relating to approval and maintenance of drug applications, regulatory submission process and requirements, including post marketing requirements.

Demonstrated proficiencies with auditing, and CAPA (corrective and preventive action) development/management.

Establish and manage Quality policies and procedures for receipt, manufacturing, packaging, testing, documentation, storage, and transporting applicable products.

Minimum of ten years QC/QA technical pharmaceutical leadership experience.

Bachelor's Degree in Control Management, Finance, or Audit

Member of the management control team at site level (Reporting, Headquarters, and business controller)

Controlling interface at Intra-group management requests.

Management control support for the site.

Provide analysis of monthly results to the management (explain variance vs. budget, month N-1 on all P&L and activity analysis lines)

Develop or implement standard management control tools.

Minimum 10-12 years’ experience in aseptic production/processing cleaning practices within a regulatory environment, including 5 years in a managerial role

Manage inspection readiness program and activities and provide support during regulatory inspections and customer audits.

Strong verbal and written communication skills

Strong knowledge of business process needs of quality assurance

Ability to enable and empower managers and hold them accountable for results

Supervise, coach and develop Quality staff

Collaborate with the management team to develop, implement and continuously improve quality-focused standards, procedures, and processes

Manage team to conduct preparatory, initial, and follow-up inspections for all features of work to ensure all project requirements are met

Must have 5+ years of experience / knowledge of electrical construction

Update the Project Manager regarding all quality issues as well as the progress of problem resolutions

Strong knowledge related to NEC code

Experience in Low Voltage systems (Fire Alarm, Tele-Data, Security, Audio/Visual, etc.)