The 2nd shift QA Supervisor of Quality Operations main focus is on the Quality oversight of all production activity with a real time focus of process and systems auditing. This activity will include the management of a team of QA auditors and Aseptic Core Monitors (ACMs). This individual will review all Production activity including room line clearances, reviewing production operations in-process controls, working closely with Production management to identify and perform manufacturing investigations, provide aseptic technique coaching feedback to Production operators and management. Additionally, they recommend, implement, and coordinates quality assurance program improvements to prevent or eliminate defects in new or existing products. 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. This position will provide training to the QA Auditors and ACMs on quality related issues.
- Responsible for real time decisions and defining the path forward related to aseptic manufacturing deviations. Take immediate corrective and preventative action when non-compliance and/or undesired behavior by personnel in the facility is observed.
- Supervise the Quality Auditors and ACMs on each shift to ensure the daily observation duties by the team are completed based on Operations scheduling.
- Partner with Operations/Quality/Operational Excellence Leadership to make recommendations for enhancements to aseptic processes and completion of required trainings.
- Providing regular performance feedback (praise and developmental) to members of QA Quality Operations team.
- Assists in recruiting, interviewing and hiring qualified employees to fill open positions.
- Planning, assigning and directing work.
- Assisting the QA Manager of Quality Operations in addressing complaints and resolving personnel problems within the department.
- Maintaining confidentiality of information.
- Review/update QA departmental SOPS as applicable.
- Responsible for the overall direction, coordination and evaluation of the off-shift team.
- Bachelor's Degree (BS or BA) in a science related field (i.e. math, chemistry, biology) required.
- Two years of Quality Professional experience in a GMP environment or a combination of education and work experience.
- Ability to apply supervisory skills to influence personnel in other departments to complete activities required to disposition executed batch records, i.e. investigation conclusions.
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.
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