Job Description
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Responsibilities
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Responsibilities
- The incumbent will be responsible for maintenance of cGMPs (current Good Manufacturing Processes) within assigned areas in conformance with our Company Policies and in compliance with Health Agency regulations and all other governing agencies.This may include ensuring cGMPs are utilized for all batch/facility cleaning documentation, change control and day-to-day operations for a bulk sterile/aseptic process.As needed reviews and approves batch records, investigations, facility/process qualification and validation studies, participates in Quality audits of the manufacturing areas to ensure compliance to cGMPs.
- The successful candidate will also support pre-approval inspection and regulatory filing related activities.
- The candidate will support sampling requirements and perform material control functions and accountability reviews.
- Candidate routinely makes decisions using cGMP/process knowledge and works with customers to resolve problems and meet the needs of Quality and Production. Follows site safety requirements.Authors, reviews, and approves data and documents such as methods, procedures, and protocols.
- Completes assigned projects and tracks/reports metrics.
- The Quality Analyst role supports the production area that operates on a shift schedule and therefore can expect to work shift work.
- The open position is currently assigned to an aseptic, antibiotic production area though assignment of work can apply across the Quality department at the site.
- Bachelor's Degree Scientific (biology, chemistry, engineering, other)
- Minimum two (2) years experience in the pharmaceutical industry or quality assurance/control
- Demonstrated verbal/written communication and decision making skills
- Experience with GMP/compliance requirements for food or pharmaceutical industry; technical writing skills; understanding of computer system SAP and Office products; basic statistical understanding; sterile/aseptic processing experience