Biotech Quality Assurance Specialist (Contract)

Precision Life Sciences - Boston, MA

Precision Life Sciences is seeking a contract Quality Assurance Specialist for our client in the biotechnology / life science industry, to provide Quality oversight for Manufacturing and Quality Operations.  This includes documentation review of executed Quality records. This candidate will also assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. The role will be critical in supporting the growing needs of our internal and external manufacturing.

Our client is looking for someone local to the Boston area or willing to relocate here.

 

Key Areas of Responsibility:

  • Partner with the members of QA, QC, and Manufacturing in batch production activities providing quality guidance of quality issues
  • Attend and participate in Quality Meetings
  • Responsible for escalation of quality deficiencies identified in the production process
  • Maintains and monitors key quality systems such as deviations, investigations, CAPA; which includes the review of trended data to identify areas for improvement
  • Review Batch records, deviations, investigations, documents, validation protocols, and reports compliance to internal and GMP standards
  • Write and revise master specification and inspection records
  • Review and approve raw material and component testing for manufacturing.
  • Support manufacturing with line clearance
  • Write and revise Standard Operating Procedures (SOPs) and applicable policies as required
  • Interacts with personnel from all departments of Lyra Therapeutics to ensure GMP compliance
  • Performs reviews of internal and external batch documentation, records, and reports
  • Review QC data generated as to the acceptance to established product specifications
  • Perform lot disposition activities for intermediate sub-assemblies and finished product
  • Provide guidance and support with the resolution of investigations and CAPA’s
  • Interact with contractor personnel or consultants regarding validation and qualification activities
  • Assist in the scheduling and maintenance of Quality Assurance activities and systems.
  • Support material management from and to external GMP warehouse
  • Review and analyze environmental monitoring reports and determine corrective actions for excursions

Requirements

  • BS in a scientific discipline or equivalent with a minimum of 7 years experience in an FDA regulated industry or MS in a scientific discipline or equivalent with a minimum of 5 years experience in an FDA regulated industry
  • Experience with Quality Assurance oversight and support for all phases of clinical trials
  • Demonstrate confidence in the knowledge of Good Manufacturing Practice (GMP) regulations.
  • Demonstrate attention-to-detail, problem-solving, and ability to make decisions quickly
  • Demonstrated ability to effectively organize and execute tasks. Strong verbal and written communication (including presentation) and CMO/ CRO management skills
  • Knowledge and previous experience with GMP, 21CFR Part 210- 211, 21CFR part 4, and 21 CFR Part 11
  • Ability to work independently and in a team environment
  • Ability to positively resolve conflict
  • Flexibility for changes in work priorities
  • Experience working in cross-functional teams and managing the relationships and expectations of several key stakeholders
  • Experience working collaboratively with CMO’s (Contract Manufacturing Organizations)


Posted On: Wednesday, August 17, 2022



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