This position performs quality assurance duties at the assigned facility to prevent or eliminate defects in products for filling operation or in final inspection and packaging operations. This individual must work in a detail-oriented, compliant manner in a high stress environment where adherence to deadlines is critical. The individual must display exemplary level of integrity at all times.
ESSENTIAL FUNCTIONS · Follows standard operation procedures and QA paperwork to ensure compliance with Good Manufacturing Practices (GMP), accuracy, completeness and accountability · Monitor and conduct in-process inspections of filling/packaging lines for cleanliness · Verify components staged for filling/packaging operations by checking batch documents to ensure all components are correct, lot number and expiration dates and any on line inspections as required · Performs all necessary line clearance duties · Document, verify and sign all QA forms and line clearance forms · Evaluate quality issues with QA and with investigations providing necessary information and documentation when needed · Supports and actively participates in team, department and business initiatives to achieve pre-determined goals · Support of manufacturing schedule and changes · Maintain compliance to GMP’s and procedural reading · Retrieve samples filled (finished product) according to SOP or product specific protocol for analytical or microbial testing · Perform inspections on filling/packaging lines during operation and document all inspections/observations on corresponding batch folder paperwork · Perform visual inspection of compounding equipment for cleanliness · Required to communicate information with key departments as directed by QA management
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.
· Good communication skills (written and verbal) · Ability to work well with people and independently · Experience in a Quality environment · Must have knowledge of cGMPs and SOPs · Must be able to follow written and verbal instructions and ability to read and understand SOPs. · Basic mathematical skills ·
SAFETY REQUIREMENTS Safety glasses, close-toed shoes and latex gloves are required in many areas within the facility
EDUCATION AND EXPERIENCE
High School Diploma or GED equivalent
Some college education preferred
Pharmaceutical manufacturing or QA monitoring experience
*A Certificate program with experience or combination of education and experience may be considered equivalent.
JOB PREREQUISITES · 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. o Ability to read and interpret standard documents such as: procedure manuals, employee handbook, job related publications. Ability to write routine reports and correspondence.
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.
Some lifting up to 30 pounds and moving boxes will be required
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 apply deductive reasoning and analytical thought to understand complicated issues. · Ability to receive instructions and follow work rules and company policies. · 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.