Quality Control Laboratory Manager

Pisgah Labs Inc - Pisgah Forest, NC

Full-time

QC Manager

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.

Summary

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.

Essential Functions

  • Ensure quality of work, productivity and planning for the quality control department meets regulatory standards and company needs
  • Organize, schedule and direct workflow of Quality Control department to meet company milestones and timelines
  • Predict technology transfer/project implementation costs for the Quality Control department
  • Oversee all Analytical Activities associated with Active Pharmaceutical Ingredient manufacturing including Analytical Research and Development activities
  • Schedule employees to cover 3 shifts and weekends
  • Follow detailed directions for lab analyses and maintain detailed record keeping in GMP laboratory notebook
  • Direct supervision and training of QC Analysts
  • Review lab notebooks and associated documentation for accuracy and provide feedback
  • Develop, modify, improve and validate Analytical Methods
  • Operate, maintain and calibrate analytical equipment and instruments and prepare Capex reports for instrument repair, replacement or additions
  • Write, review and implement SOPs, Standard Analytical Methods, and CAPA to stringent regulatory requirements.
  • Senior Quality Control signing authority
  • Write, investigate, execute and review OOS/OOT/LD/PDNC
  • Plan and schedule analytical support for R&D
  • Write and execute method validation/verification/transfer protocols
  • Participate in routine analyses and inspections
  • Perform complex mathematical operations as used in scientific operations
  • Handle various chemicals such as acids, caustics, flammables, etc. safely and efficiently
  • 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

Attributes

  • A legal U.S. citizen
  • Ability to pass a pre-employment respiratory physical exam, hearing test and drug/alcohol screen
  • Ability to read and write in English
  • Ability to pass a criminal background check
  • Ability to work independently with little or no supervision to complete assigned tasks
  • Extensive knowledge of HPLC, GC and Spectroscopic techniques
  • Extensive knowledge of Regulations and guidance documents (FDA, ICH, PIC/S, USP, EP)
  • Availability 24 hours a day, 7 days a week
  • Ability to solve complex problems and implement necessary corrections in timely manner
  • Ability to manage, teach and train other employees
  • Strong numerical and analytical skills
  • Ability to read and understand safety rules and procedures for handling chemical substances
  • Working knowledge of Microsoft Office Products
  • Ability to wear and utilize any necessary personal protective equipment
  • Ability to communicate in an open and honest manner
  • Support a strong work/safety ethic throughout the organization
  • Ability to function as a team player with good interpersonal skills
  • No known or uncontrolled allergies to common chemicals used in a pharmaceutical laboratory

Supervisory Responsibilities

This position has supervisory responsibilities of managing a small 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 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 Bachelor’s in Analytical / Organic Chemistry or related field. Higher level degrees in other sciences will be considered with relevant experience.
  • At least 7 years’ experience in a GXP analytical laboratory environment
  • At least 2 years’ experience in management and/or supervision of other employees
  • At least 2 years’ experience in project planning, scheduling and coordination

Compensation

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.

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.

Pisgah Labs welcomes all applicants equally. If you are smart, hard-working and honest you belong at our company!

Job Type: Full-time

Experience:

  • Management/Supervision: 2 years (Preferred)
  • GxP laboratory: 7 years (Preferred)

Education:

  • Bachelor's (Preferred)

Location:

  • Pisgah Forest, NC (Required)

Shifts:

  • Morning (Preferred)
  • Mid-Day (Preferred)
  • Evening (Preferred)
  • Graveyard (Preferred)

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off
  • Relocation assistance
  • Professional development assistance

This Job Is Ideal for Someone Who Is:

  • Dependable -- more reliable than spontaneous
  • Adaptable/flexible -- enjoys doing work that requires frequent shifts in direction
  • Detail-oriented -- would rather focus on the details of work than the bigger picture
  • Achievement-oriented -- enjoys taking on challenges, even if they might fail
  • Autonomous/Independent -- enjoys working with little direction
  • High stress tolerance -- thrives in a high-pressure environment