Sr. Quality Assurance Specialist

Role: Sr. Quality Assurance Engineer. 100% onsite. Not a QC role.
We need QA candidates who have owned manufacturing investigations end to end, not supported them.

Must-have experience
5 years Quality Assurance (QA, not QC)
GMP deviation and manufacturing investigations ownership, not "assisted with "
CAPA management including effectiveness checks
Root cause analysis with named methodology (5 Whys, Fishbone, FMECA)
Customer complaint investigations frequently missing; direct customer interaction preferred
Internal audits and ISO 9001
Change control
Validation support (process, cleaning, IQ/OQ/PQ)
Pharmaceutical or chemical manufacturing environment

Also valued
Hosting customer, certification, and regulatory audits
Statistical evaluation and process trending (SPC)
Delivering GMP/GDP training to site personnel
Supplier quality collaboration

Education
BS in Chemistry, Biology, Biochemistry, Chemical Engineering, or Microbiology preferred. Pharmacy (B.Pharm) and related science degrees will be considered where QA experience is strong.

Industries
Pharmaceutical manufacturing, biotech manufacturing, chemical manufacturing, reagent/life sciences. Medical device as a secondary option.

Job Description: Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.

Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.

QUALIFICATIONS:·        

• • Minimum of five (5) years of experience in quality engineering or a related role required
  • Experience working within pharmaceutical, biotechnology and/or chemical environments required
  • Experience working within cGMP/ISO 9000 regulated environments required:

MAJOR JOB DUTIES AND RESPONSIBILITIES:      

• • Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirements
  • Leads customer complaint investigations requiring direct interaction with customers as well as raw material suppliers
  • Manages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirements
  • Performs internal audits at other *** sites and may participate in supplier audits as required
  • Responsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actions
  • Ensures facility cGMP compliance is maintained and identifies/implements improvement programs as required
  • Provides GMP and GDP training to site personnel
  • Leads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAs
  • Works with and provides input to Management of Change process
  • Performs statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and products
  • Works collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaint
  • Partners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teams
  • Works with all departments to investigate and resolve process and product quality issues
  • Performs other duties as assigned with or without accommodation

KNOWLEDGE, SKILLS AND ABILITIES:      

• • Excellent writing and presentation skills
  • Demonstrated ability to accomplish goals through others
  • Demonstrated familiarity with chemical nomenclature and Quality Control testing and methods
  • Ability to merge divergent resources into an effective and efficient cross-functional team
  • Highly detail oriented with demonstrated strong analytical and problem solving skills
  • Ability to navigate in a matrixed environment and work collaboratively in a team environment
  • Excellent organization and project management skills
  • Ability to interface effectively with people at all levels of the organization, from executive to production line

WORKING CONDITIONS:

The work environment is a manufacturing facility, and the appropriate PPE will be required in designated areas. Domestic travel is required on occasion.

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