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
- 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.
- 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.