Pisgah Labs is an FDA licensed GMP Active Pharmaceutical Ingredient (API) manufacturer in Pisgah
Forest, NC that is currently seeking to fill an open role for a QC Manager. Pisgah Labs, Inc. offers benefits such as medical, dental and vision, 401K, and ancillary insurance benefits to employees. The company offers a PTO program and paid holidays.
The Quality Control Manager is responsible for the management and oversight of the Quality Control
Department. The applicant must have extensive working knowledge of standard analytical equipment
(including HPLC/GC) and data interpretation. Applicant must have considerable working knowledge of governing body regulations as they pertain to the Quality Control department (FDA, ICH, USP, EP, ect).
The position is responsible for ensuring the accuracy and testing of all raw material, in-process control, active pharmaceutical ingredient, and stability testing. The position involves organization, scheduling and planning of the instrumental and human resources available to achieve company milestones and project implementation goals. The position involves writing, investigation and execution of out-of- specification reports and lab deviations as well as Corrective and Preventive Actions. The Quality
Control Manager will direct analytical method development activities as required for raw materials, in- process controls, active pharmaceutical ingredients, and cleaning analysis methods. The position involves overseeing method transfer/verification/validation activities and writing and execution of the associated protocols and final reports. The Quality Control Manager is also an alternate emergency coordinator for the Emergency Response Plan. The Quality Control Manager will be a part of the audit team for internal, regulatory and customer audits. The Quality Control Manager will be responsible for predicting project cost and preparing capital expenditure reports for senior management for instrumentation needs in the Quality Control laboratory. The Quality Control Manager is responsible for a small but expanding, dedicated group of analytical chemists and reports directly to the site manager.
This position has supervisory responsibilities of managing a small department of analytical chemists with varied levels of knowledge and skill.
Employee will generally work in a temperature controlled GMP Laboratory and will have exposure to a wide variety of chemical materials. Employee is expected to wear lab coat and any necessary PPE.
Employee will utilize general office equipment including computers, printers, office machines and other office related items. Employee will also have frequent exposure to the manufacturing facilities, bulk chemicals, and Hazardous materials.
The position requires moderate physical exertion such as operating equipment, repetitive motions, standing and sitting for varying periods. The employee will also need the physical ability to lift moderately heavy objects (at least 50 pounds). Employee may be exposed loud sounds, running machinery, bulk chemicals and varying temperature changes in manufacturing facilities.
Position Type/ Expected Hours of Work
This is an exempt, full-time salaried position. Employee should be available to work shifts, overtime and weekends as required by management and project goals.
The position may involve travel to train, assist clients or attend industry functions.
Salary Dependent on Experience. Base $65,000/year. New employees are hired as full-time probationary employees, under a 180-day probationary period, during which skills and abilities will be evaluated. After the successful completion of the probationary period, the employee will be re-classified as a full-time regular employee. Employees will become eligible for available company benefits after 90 days employment.
Pisgah Labs, Inc. is an Equal Opportunity Employer. Pisgah provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Pisgah
Labs will not tolerate discrimination or harassment based on any of these characteristics. Pisgah Labs is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
Pisgah Labs welcomes all applicants equally. If you are smart, hard-working and honest you belong at our company!
Job Type: Full-time
This Job Is Ideal for Someone Who Is: