SUMMARY:The Quality Control Manager will implement and coordinate QC analytical laboratory functions at the Decatur location. Will ensure consistent quality of production by developing and enforcing good practice systems, validatingprocesses, providing documentation, managing staff, and fully understand the requirements for the products.
ESSENTIAL FUNCTIONS: • Monitoring departmental activities to ensure work is completed within the targeted timelines.• Ensuring completion of Analytical R&D method transfers into Quality Control laboratory.• Reviewing QC documents that support analytical requirements in accordance with USP guidelines.• Generating summary reports and trend analysis reports• Ensuring OOS investigations to address departures from written SOP's are completed andcorrective actions are implemented and effective. • Provides guidance and training to staff and motivates individuals to achieve results.• Develops and monitors department budgets. • Coordinates department activities, ensuring production needs are safely and effectively met• Establish policies, procedures, standards and objectives for the provision of services and coordinates with other departments to provide maximum level of services• Ensures GMPIGLP Compliance• Oversees training and ensures staff competencies
ADDITIONAL RESPONSIBILITIES:•To ensure staff is trained•Troubleshooting inchemical testing and instruments•Ensure testing are conducted in accordance with SOP's and approved methods•Assisting in the hiring process of new personal (Chemists and Technicians)
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE: Minimum BS/BA in Chemistry or health related field. At least five years’ experience in a QC department including at least three years of Supervisory/Managerial experience preferably in the biotech/pharmaceutical industry.
JOB PREREQUISITES: • Ability to meet attendance standards. All full-time employees are required to work a 40 hour week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. • Administrative capability to supervise group of chemists. • Strong working knowledge of HPLC, GC and Spectroscopic analysis. • Knowledge of FDA (CDER) regulations, European Directives, ICH guidelines will be plus. • Excellent communication of cGMP/GLP regulations; assay qualification using both USP, EP and ICH methodologies. • Ability to manage and provide technical support to all phases of analytical QC testing and to accurately interpret results.
PHYSICAL DEMANDS AND WORK ENVIRONMENT: While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use. Additional physical requirements include the ability to hear accurately the spoken word with moderate office noise (or plant noise).
Mental requirements include: •Ability toapply deductive reasoning and understand complicated issues. •Ability to receive instructions, follow work rules, and company policies. •Ability to follow safety andsecurity practices. •Ability to meetdeadlines and effectively deal with office stress. •Ability to accurately communicate ideas, facts and technical information. •Maintain confidentiality of certain information.