QC Tech III

Endo•Raleigh, NC

6h•Onsite

About The Position

The Quality Tech III analyzes process samples as received and performs non-routine analysis as requested. She/he analyzes finished goods and raw materials by chemical, physical, and instrumental means to ensure quality as needed. She/he will typically work on a rotating shift schedule. Acts as a mentor for other technicians.

Requirements

Associates of Science (AS) or Bachelor of Science (BS) or equivalent life science degree preferred. Appropriate experience may be a suitable replacement for degree.
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.
Must be able to comprehend and independently carry out written procedures, record results and observations, and perform mathematical calculations.
Requires familiarity with all laboratory procedures and equipment and an understanding of instrument operations.
Ability to differentiate colors, as demonstrated by passing a test designed to identify color blindness (such as the Ishihara test). If testing criteria are not met with uncorrected vision, the use of color correcting glasses may be used as long as testing criteria are met while using them.
Functional/Technical Skills, Priority Setting, Written Communication Customer Focus, Organizing
Sound and correct technical judgments are required during routine analysis.
Strong computer skills.
Must be able to wear the required personal protective equipment (PPE), such as hard-hat, steel-toe shoes, safety glasses, and other equipment as deemed necessary by EH&S, leadership team, corporate, or safety guidelines for the position.
Must be able to work a rotating12 hour shift schedule of (7pm-7am / 7am-7pm) in addition to occasional overtime as needed.

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.
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.
Completes all required Compliance trainings in a timely manner.