QA Supervisor (Laboratory Operations)

  • location: Exton, PA
  • type: Permanent
  • salary: $75,000 - $85,000 per year
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job description

QA Supervisor (Laboratory Operations)

job summary:
Supervises the Quality Operations function for the Analytical Services Laboratory. Host customer and regulatory audits, coordinates the responses to customer audit observation, customer complaints and requests for information / documentation. Ensure quality system is in place and maintained.

 
location: Exton, Pennsylvania
job type: Permanent
salary: $75,000 - 85,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Participate in customer, ISO, corporate QA, and regulatory audits, as required.
  • Assure execution of internal quality audits, management review, etc according to established procedures for the assigned areas / locations.
  • Provide response to audit observations, and customer complaints.
  • Assure investigations, CAPA, change control, calibrations are conducted, documented, and where applicable, trended appropriately.
  • Review / approve OOS investigations
  • Work with / interface with Laboratory personnel in the assigned areas for continuous improvements related to CAPA and / or customer or regulatory requirements.
  • Maintain information / statistics for assigned areas, for inclusion in the regular Management Review.
  • Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness.
  • Leads and manages key projects/initiatives related to Quality and ensures that progress is within expected guidelines, budget and timelines.
  • Review documentation for compliance to policies and procedures, cGMPs and applicable ISO standards.
  • Lead or assist in conducting quality audits (internal or supplier), as assigned.
  • Performs other duties as assigned based on business needs.
  • Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
 
qualifications:
  • Bachelor's in Science or Engineering, or commensurate experience
  • 3-5 years of experience
  • Attention to detail
  • Ability to work independently
  • Ability to communicate professionally
  • Knowledge of cGMP and applicable ISO standards.
  • Experience in quality assurance role
  • Experience with customer interface and meeting customer expectations.
  • Experience as a Quality Engineer (desirable), process improvement activities, etc
  • Working knowledge of pharmaceutical industry requirements
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute in Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company's safety policy at all times
  • Able to comply with the company's quality policy at all times.
 
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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