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Endo · 5 days ago

QC Tech III

Raleigh, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

Endo is committed to improving lives through quality healthcare, and they are seeking a QC Tech III to ensure product quality in their laboratory. The role involves analyzing process samples, performing various tests, maintaining accurate records, and mentoring other technicians.

Pharmaceuticals

Comp. & Benefits

Responsibilities

Ability to proficiently perform all functions of a Quality Tech II

Must be completely trained and proficient in all rotating areas of the QC Lab, i.e., PAP Controls, APAP Controls, and Finished Lot testing

Performs in process testing for our internal customers

Performs finished goods, returned goods, and stability testing for our external customers as needed

Performs testing on all bulk raw materials as needed

Performs specified analysis on bulk raw materials, all process control samples and and reports results in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques

Performs specified analysis on all finished goods and non-routine customer tests using approved written procedures and laboratory techniques as needed

Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system. Demonstrates good documentation skills as a documentation reviewer

Prepares all standards and reagents needed for proper execution of analytical methods and procedures

Troubleshoots and performs routine maintenance on laboratory instrumentation and takes ownership of continued education with regard to instrument maintenance and troubleshooting

Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy

Takes on a leadership role. Point of contact for plant and QC/QA management. Ensures that the lab runs smoothly and all required testing is being addressed by staffing areas appropriately according to technician training

Other duties as assigned with or without accommodation

Assists in any non-routine analytical work needed to solve plant problems

Works on solving problems and implementing improvements in a teaming environment

Demonstrates advanced problem solving skills to analyze and help complete failure investigations and testing problems

Aids in performing any quality control related tasks such as resampling, raw material testing, and performing analysis needed to validate methods and equipment

Participates in a certified 5S Workplace System to ensure good housekeeping and organization

Assists with training others as needed

Participates in customer audits and Lab tours

Qualification

QC Lab experienceCGMP knowledgeLaboratory instrumentationAnalytical methodsDocumentation skillsOrganizingComputer skillsProblem solvingTeamworkWritten communicationCustomer focus

Required

Ability to proficiently perform all functions of a Quality Tech II

Must be completely trained and proficient in all rotating areas of the QC Lab, i.e., PAP Controls, APAP Controls, and Finished Lot testing

Performs in process testing for our internal customers

Performs finished goods, returned goods, and stability testing for our external customers as needed

Performs testing on all bulk raw materials as needed

Performs specified analysis on bulk raw materials, all process control samples and reports results in a timely manner by telephone or computer entry using approved written procedures and proper laboratory techniques

Performs specified analysis on all finished goods and non-routine customer tests using approved written procedures and laboratory techniques as needed

Maintains accurate and precise records of all laboratory analysis using appropriate Mallinckrodt recordkeeping system

Demonstrates good documentation skills as a documentation reviewer

Prepares all standards and reagents needed for proper execution of analytical methods and procedures

Troubleshoots and performs routine maintenance on laboratory instrumentation

Takes ownership of continued education with regard to instrument maintenance and troubleshooting

Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy

Takes on a leadership role

Point of contact for plant and QC/QA management

Ensures that the lab runs smoothly and all required testing is being addressed by staffing areas appropriately according to technician training

Education: Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree

Experience: 2 – 4 years laboratory experience in a pharmaceutical manufacturing operation

Must have at least 2 years QC Lab experience, trained and competent in all areas, i.e., PAP Controls, APAP Controls Lab, and Finished Lot testing

Working knowledge of cGMP required