The Quality Control Specialist is responsible for coordinating, planning, and monitoring all activities of Quality Control. The Quality Control Specialist is the subject matter expert in performing a broad range of chemical tests and procedures in the laboratories or at production stations.
ESSENTIAL JOB FUNCTIONS
1. Coordinates, directs, plans, and monitors all tactical activities in Quality Control.
2. Supports maintaining an effective microbiological program.
3. Trains new laboratory staff in performing all necessary chemical tests and procedures used in the laboratories.
4. Reviews and approves analytic and microbiologic reports and testing documents for raw materials and product.
5. Supports the Manager, Quality Control during cGMP inspections by third-party auditors and regulatory agencies.
6. Supports the Manager, Quality Control in establishing (when necessary), revising, and updating Standard Operating Procedures (SOPs), analytical and microbiological procedures, raw material specifications, and protocols.
7. When needed, performs routine testing and analysis of finished product, bulk in-process, raw materials, and stability samples in accordance with compendia and in-house test methods.
8. Ensures that routine maintenance, cleaning, and calibration of equipment used in the laboratories is up to date.
9. Ensures general housekeeping and organization of laboratory work spaces including bench tops, personal drawers, glassware, chemical storage cabinets, and exhaust hoods.
10. Ensures that all testing performed in the laboratories conforms to all cGMP/GLP requirements in performance and documentation of analytical testing.
11. Recommends procedures and systems to Manager, Quality Control in order to improve work flow and efficiency.
1. Performs special projects, as assigned by the Manager, Quality Control, which enhance and contribute to the growth of the Quality Control Department.
2. Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Control.
3. Supports the Winner’s Circle and Blistex Quality System processes.
EDUCATION AND EXPERIENCE
1. A BS/BA in Chemistry, Pharmacy, or related discipline; or, its equivalent in training and experience is required.
2. The knowledge and skills required for this position are typically acquired in 4 to 5 years of experience in a similar or related industry.
SKILLS AND ABILITIES
1. Considerable interpersonal skills are required to interact with internal and external customers.
2. A comprehensive knowledge of all aspects of quality control.
3. Good understanding of compendia such as USP/BP/EU or FCC.
3. Must possess a comprehensive understanding of cGMP/GLP regulations as they relate to the testing and reviewing of cosmetics and pharmaceuticals.
4. Knowledge of computerized data acquisition and analysis systems, such as HP CHEM Station, Waters Millennium, or PE TotalChrom is required.
5. A comprehensive knowledge of laboratory instrumentation.
6. Must possess good oral and written communication skills in Business English.
7. Must have good math and strong analytical problem-solving skills.
3. Computer literacy in a Windows environment is required. Familiarity with Excel, Word, and/or Access database is preferred.
4. Must possess a good understanding of the safety standards and hazards associated in a Quality Control environment.
5. The ability to prepare clear and accurate documentation.
6. Ability to work independently and meet deadlines on a multitude of tasks.
7. Must possess good organizational ability.
8. Must be flexible to work 1st, 2nd, 3rd, or a modified work shift, as departmental needs demand.
9. Willingness to accept other duties, as assigned.
10. Must be discreet with confidential information to which he/she has access.
1. Good working conditions; however, occasionally exposed to elements such as fumes and odors.
2. Physical demands include standing about 25% of the time and sitting about 75% of the time.
MENTAL AND PHYSICAL DEMANDS
Overtime requirements are dependent upon departmental demands, inclusive of weekends.