Description

Highland Laboratories

An Equal Opportunity Employer

JOB DESCRIPTION 

This organization believes that each employee makes a significant contribution to our success. That contribution should not be limited by the assigned responsibilities. Therefore, this position description is designated to outline primary duties, qualifications and job scope, but not limit the incumbent or the organization to just the work identified. It is our expectation that each employee will offer his/her services wherever and whenever necessary to ensure the success of our endeavors.

Title: Quality Control Chemist

Department: Quality Control

Reports To: Quality Manager

Classification: Nonexempt

Introduction Period: Up to 90 days

Job Type: Full-time

Position Summary:

Quality Control professional to perform all activities associated with QC release testing for incoming raw materials and finished goods disposition. QC lab chemist job requires a 4-year degree in chemistry with preferably 1-2 years of experience in a QC lab, or chemistry field however no industrial lab experienced is required. Candidates should be familiar with analytical testing concepts, practices, instrumentation and equipment procedures and maintenance, and preferably has a working knowledge of cGMP and FDA regulations. This is an entry level chemist role with a growing company therefore career advancement is a given.

-Perform data review, analysis, identification of trends, and complex problem solving

-Write and review QC SOPs and qualification/validation protocols and reports

-Perform instrumental analysis using FTIR, HPLC, GC, and ICP

-Perform microbial analysis of products

-Experienced with wet chemistry and analytical chemistry

-High level organizational skills, strong leadership skills, team oriented/collaborative

Marginal Functions

Ø Maintains equipment calibration schedule and ensure that all required calibrations and maintenance are completed in a timely fashion

Ø Perform FT-IR identification on incoming raw materials

Ø Perform HPLC, GC, and ICP analysis on incoming raw materials and outgoing finished products

Ø Perform microbiological testing on all incoming and outgoing products

Ø Work with Master Planner and Inventory Manager on all rejected products, labels, and components. Coordinate any return / reorder

Ø Work with all departments to coordinate workflow

Ø Maintain open communication with Purchasing, Sales, and all other Departments

Ø Work with Receiving Department to expedite materials based on production requirements

Requirements

Physical Requirements:

Ø Vision, hearing, and speaking to meet performance standard

Ø May be required to wear a respirator

Ø Manufacturing environment

Ø Able to lift up to 35 lbs

Equipment used and strong theoretical knowledge:

Ø HPLC-MS/MS

Ø ICP-MS

Ø GC-FID

Ø FT-IR

Ø Iso-GRID Microbial Analysis

Work Environment:

Ø May require overtime during peak periods or as business needs dictate

Ø Requires compliance to all department and company Good Manufacturing Practices and Standard Operation Procedures

Ø Requires ability to work in an environment that contains high temperatures, fumes, dust, odors, noise, chemicals, temperature variations, and varying levels of ventilation

Ø Requires team-orientation, common sense and good judgment, professional behavior, effective communication (oral and written), and problem-solving skills

Qualifications:

Ø Four-year Bachelor’s Degree in Laboratory Science related field preferred

Ø Two years of experience performing routine, standardized analytical tests and laboratory preferred

Ø Familiarity with State of Oregon Food Handling regulations

Ø Familiarity with laboratory analytical equipment

Ø Working understanding of current Good Manufacturing Practices (cGMP)

Ø Possess effective communication skills with both technical and non-technical personnel within team management environment

Ø Ability to negotiate with outside vendors

Ø Experience with personal computers (Excel, Word, E-mail) and other PC or server applications

Ø Requires ability to take and follow directions, time management skills, organizational development and improvement

Ø Critical thinking and analytical skills required to perform the essential job functions listed on this job description