Job Description SUMMARY Performs quality assurance duties to prevent or eliminate defects in products for sterile filling operation or in final inspection operation. The QA Supervisor of Quality Operations schedules and reviews in-process auditing of all facility operations. This individual will work in a detail oriented, compliant manner to ensure the facility operations align with Akorn policies and procedures as well as cGMPs. The QA Supervisor of Quality Operation reports directly to the QA Manager of Quality Operations.
ESSENTIAL FUNCTIONS .
Trains QA Technicians on proper technique and procedures.
Schedules auditing assignments to staff.
Reviews daily in process audit paperwork.
Documents and investigates deviations, and non-conformances
Assists in Annual Product Review/Annual Report Compliance
Monitors the production processes and ensure consistency of procedures.
Involvement in decision making to stop production if quality standards are not being met.
Oversees the verification of green release stickers issued to operations.
Oversees the automated inspection and AQL sampling of finished products.
Oversees the transfer of finished products to other Akorn facilities..
Reviews environmental monitoring of controlled areas.
Audits the maintenance of a clean sanitary environment.
Reviews and calculates theoretical yields for completed raw material records and cards.
Reviews mean kinetic temperature calculations
Reviews System Alarm Messages.
Works with CAPA Coordinator or designee to ensure items are completed, documented and timely.
Assists with CAPA effectiveness checks
Directly responsible for performance reviews, goal setting and personnel development plans for QA Technician I and II
Recruiting, interviewing and hiring qualified employees to fill open positions.
Addressing complaints and resolving personnel problems within the department
Maintaining confidentiality of information
Auto req ID 1214BR
Qualifications QUALIFICATIONS To perform this job successfully, an individual must be detail-oriented and possess the ability to multi-task and work on multiple projects simultaneously. 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.
SAFETY REQUIREMENTS Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility
EDUCATION AND EXPERIENCE
Bachelor's Degree (BS or BA) from a 4 year college or university
5-10 years demonstrated excellence in in the pharmaceutical or related industry
All full-time employees are required to work a 40 hour week. At times, additional hours during the weekdays, evenings and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopea, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820) and other FDA regulations and guidance's.
Have general math skills; adding, subtracting, multiplication, division and percentage calculation. Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.
Able to use personal computer and standard office equipment such as fax and copy machines, calculator, and printers. Aptitude to learn computer programs as needed (i.e. Word, Excel) in addition to other business applications.
Strong verbal and written communication skills. Resourceful and well organized.
Ability to read and interpret standard documents such as: procedure manuals, employee handbook, job related publications. Ability to write routine reports and correspondence.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL DEMANDS/ MENTAL 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, PC use and evaluation of test specimens.
Mental Requirements include:
Ability to write, read and apply technical scientific writing, procedures and quality policies
Ability to work independently in an efficient and detail-oriented manner.
Ability to work on multiple projects and priorities in a concurrent manner.
Ability to work in an independent manner, as well as a group environment
Ability to apply deductive reasoning and analytical thought to understand complicated issues.
Ability to receive instructions and follow work rules and company policies.
Ability to follow safety and security practices.
Ability to meet deadlines and effectively deal with a high level of office stress.
Ability to maintain confidentiality of work assignments and personnel issues
Company Overview Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
EEO Statement Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.