header photo

Executive Director - QA/QC Rutgers, NJ

This position is responsible for the organizational and programmatic elements of Quality Assurance, Quality Control, Microbiology, Training & Documentation, CAPA / Investigation and Validation. Key responsibilities relate to sterile product manufacture, aseptic processing and control of environmental integrity, in accordance with applicable regulatory criteria and industry standards. This responsibility includes, but is not limited to, the effective planning and organization of personnel and workflow utilization (throughout the product life cycle) in order to implement the timely submission, approval, validation, testing and release of products and processes. This requires consistent successful application of internal quality system policies, procedures, and external regulations and standards that govern the products manufactured, labeled, tested, stored, promoted and/or distributed. In addition, the position ensures that short and long term plans are made and executed so that the current and future facilities and systems, manufacturing capacity and capability, and materials needs are met

Responsibilities

  • Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and goals
  • Insure compliance with the federal regulation and administrative policies of the laboratories
  • Develop and maintain quality systems
  • Coordinate and review facility calibration and validation programs
  • Conducts FDA inspection and furnishes the response of FDA 483
  • Review and approve investigations (OOSs, Non-Lab OOSs and deviations)
  • Review and provide appropriate information to regulatory for ANDA/NDA filings
  • Review of quality performance metrics/trends and analysis
  • Review vendors audit program
  • Annual record review
  • Maintain and coordinate the facility QA Documentation System (SOPs, Master Batch Records, and Specifications)
  • Investigate customer and product complaints
  • Review and approve validation protocols.
  • Carries out responsibilities in accordance with the organization's policies and applicable laws.
  • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems;
  • Assist and Manage Quality Assurance, Quality Control, Microbiology, and Validation departments with work related projects.

Qualifications

  • Bachelor's degree (BS) in the Life Sciences (e.g.,Chemistry, Microbiology, Biology, Biochemistry) or Pharmacy from an accredited four-year college or university
  • A minimum of five to ten years of experience related to the pharmaceutical manufacture, specializing in sterile dosage forms.

Director, Nutraceutical Health

 Director, Nutraceutical Health- Duluth, GA

 

Commercial management and leadership of cross-functional teams for short- and long-term product innovation, supervision of development process, close collaboration with regional teams in the development of commercial launch plans. Connecting to external and internal partners Additional tasks / functions(facultative): Thought leadership in analysis, insights development and ability to translate developed products into commercial plan for in-market launch (5P go-to-market plan: product, price, placement, promotion/POP, protocol). Develop brand strategies. Qualifications: Bachelor degree in marketing/business or related field MBA preferred 5+ years brand management experience, in country, regional or global role Veterinary or scientific degree in combination with MBA preferred Leadership Teamwork/cross-functional expertise Communicates effectively Executional Excellence Strategic marketing Self-awareness and personal impact

CANDIDATE DETAILS 5+ to 7 years experience Management Experience Required - NoMinimum Education - Bachelor's DegreeWillingness to Travel - Often

SKILLS AND CERTIFICATIONS [note: bold skills and certification are required] Veterinary or scientific degree in combination with MBA preferred
5+ years brand management experience, in country, regional or global role

Principal Structure Analysis Engineer - Composites - Salt Lake City

Responsibilities

  • Highly motivated structural analysis engineer with composite structures and assemblies for military and/or commercial aircraft
  • Experience with the characterization of composite materials with ASTM standard tests.
  • Analysis of laminates, sandwich structures, bonded and bolted assemblies
  • Lead composite material characterization activities including: authoring test plans and test reports, data reduction and calculation of material allowables

Requirements

MUST HAVE AN ACTIVE SECURITY CLEARANCE TO BE CONSIDERED FOR THIS ROLE

  • BS in Engineering (Civil, Mechanical, or Aerospace Engineering) or related
  • Minimum of 7 years related experience in design engineering function (Principal Level)
  • Minimum 4 years’ experience for Sr. Level Analyst position
  • Minimum of 4 years of experience with Abaqus and/or Nastran
  • Experience defining layups and ply patterns with Fibersim to generate finite element models
  • Proficiency with NX, Catia V5, Fibersim, MSC Marc, Altair Hyperworks/Optistruct, and Hypersizer desirable
  • Static structural and structural/thermal analysis
  • Buckling, stability, and modal analysis
  • Loads definition
  • Material characterization testing
  • Knowledge of composite materials and manufacturing processes
  • Script writing, workflow automation
  • Constitutive Model Development and implementation
  • Requirements definition and verification
  • Oral and written communication skills
  • Ability to work in a fast paced dynamic environment as part of a multi-discipline team
  • Strong interpersonal skills with the ability to work with a team
  • Excellent communication skills are required.

WILLING TO RELOCATE