Quality Control Manager

Position Summary:

The QC Manager is responsible for overseeing all quality control laboratory operations in support of API manufacturing. This role ensures that raw materials, in-process samples, and finished APIs meet established specifications and comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and company standards. The QC Manager leads laboratory personnel, manages testing activities, and drives continuous improvement in quality systems.

Key Responsibilities:

Oversee daily operations of QC laboratories (analytical chemistry, microbiology if applicable) Ensure timely and accurate testing of raw materials, intermediates, and finished APIs Manage laboratory scheduling, workload distribution, and resource allocation Ensure proper maintenance, calibration, and qualification of laboratory equipment Ensure compliance with cGMP, ICH, FDA, and other regulatory requirements Review and approve analytical data, laboratory investigations, and certificates of analysis (CoAs) Lead OOS (Out-of-Specification), OOT (Out-of-Trend), and deviation investigations Support internal and external audits (FDA, customer, third-party) Maintain data integrity in accordance with ALCOA+ principles Oversee method validation, verification, and transfer activities Ensure analytical methods are scientifically sound and compliant with regulatory expectations Collaborate with R&D and QA on method development and improvements Write, Review and Approve SOPs, test methods, specifications, and protocols Ensure accurate and complete documentation practices in laboratory systems Hire, train, and develop QC staff Conduct performance evaluations and provide coaching and mentorship Promote a culture of quality, safety, and continuous improvement Partner with QA, Manufacturing, Regulatory Affairs, and R&D Support batch release activities and stability programs Participate in change control processes and risk assessments Identify and implement process improvements to enhance efficiency and compliance Track and trend laboratory metrics (e.g., turnaround time, deviations, CAPAs)

Qualifications:

BS in Chemistry, Pharmaceutical Sciences, or related field (Master's preferred) 7-10+ years of experience in pharmaceutical Quality Control Minimum 3-5 years in a leadership or supervisory role Strong experience with analytical techniques (HPLC, GC, UV, FTIR, etc.) In-depth knowledge of cGMP and regulatory expectations Experience with OOS investigations and CAPA systems Familiarity with data integrity requirements Method validation and transfer expertise Strong leadership and team management skills Excellent problem-solving and analytical thinking Effective communication across all organizational levels Detail-oriented with strong organizational skills Experience in API manufacturing (small molecule preferred) Prior experience with FDA inspections Maintain a clean and safe work environment Comply with waste management practices Complete 8 hours of safety training within 6 months Complete

HAZWOPER

training within 6 months Adhere to site-wide safety and security procedures Supervisory Responsibilities This position has supervisory responsibilities of Quality Control department of analytical chemists with varied levels of knowledge and skill. Work Environment 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. Physical Demands 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 to 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. Travel The position may involve travel to train, assist clients or attend industry functions. Education/Experience Minimum Bachelors in Analytical / Organic Chemistry or related field with relevant experience. Higher level degrees are preferred. Minimum 7 years' experience in a GXP analytical laboratory environment Minimum 3 years' experience in management and/or supervision of other employees Minimum 2 years' experience in project planning, scheduling and coordination Compensation Salary Dependent on Experience. Base $85,000/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. AAP/EEO Statement 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.

Job Type:

Full-time Pay:

From $85,000.00 per year

Benefits:

Relocation assistance

Education:

Master's (Preferred)

Experience:

Analytical chemistry: 7 years (Preferred)

GMP Laboratory:

7 years (Preferred)

Language:

English (Preferred) Shift availability: Day Shift (Required) Night Shift (Required) Overnight Shift (Required) Ability to

Relocate:

Pisgah Forest, NC 28768: Relocate with an employer provided relocation package (Required)

Work Location:

In person