If you are interested in employment opportunities at ANI Pharmaceuticals, e-mail your resume to firstname.lastname@example.org
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to begin the application process. All resumes are carefully reviewed to determine whether candidates meet the needs of open positions. Resumes that do not meet our immediate hiring needs are kept on file for three months and regularly reviewed for potential matches. Due to the number of resumes received, we cannot reply to all submissions.
ANI Pharmaceuticals provides equal employment opportunities to all persons without regard to race, sex, national origin, religion, age, disability or veteran status. We encourage diversity within each department and the Company as a whole. Equal Employment Opportunity guidelines are used every time we interact with our applicants and employees and include, but are not limited to recruiting, hiring, promotion, transfer, training, discipline and termination.
Associate Director, Maintenance & Engineering
The Engineering and Maintenance Associate Director is responsible for providing leadership of the Project Engineering, Process Engineering, Maintenance, and Process Technology functions at the Baudette site. This position will direct and lead a team which supports Manufacturing, Packaging and Product Development at the site. This position will report to the Operations Director and have responsibility of capital budget, project execution and process engineering activities.
Position Responsibilities: - Organizing, managing, developing and implementing project plans, construction projects, designs, assembly of equipment, processes, and systems to ensure timely project completion, in compliance with regulatory agency requirements, internal company standards and current industry practices.
- Maximize the success rate for production operations by instituting programs to minimize mechanical failure and enhance equipment performance. Establish maintenance metrics that track and trend equipment uptime and issues. Develop corrective action plans to maximize operations. Utilize and promote Operational Excellence and continuous improvement. Develops/implements preventive maintenance program in conjunction with engineering, maintenance staff, and supervisors to improve production uptime.
- Maintain regulatory compliance thru audits, validation, change management, risk assessments, qualified drawings, corrective action plans, FMEA, and deviation support
- Direct responsibility for capital projects, as well as the site’s capital and expense budgets, cost control, project schedules, and direct/indirect expenses. Support procurement strategy, equipment expediting/projects and FAT/SAT/IOQ/PQ.
- Has operational responsibility/accountability for site maintenance activities including the repair, maintenance and installation of equipment and the maintenance of buildings, grounds, utility systems with associated infrastructure
- Reviews new product plans, and discusses equipment needs, and modifications with engineering staff
Position Requirements: Bachelors degree is a related area. 10+ years of Engineering/Maintenance experience, preferably in a regulated setting. Must have supervisory/Manager experience. Must also have leadership skills and have the ability to build and move the Maintenance and Engineering departments forward.Submit Resume
| Complete Online Application
| TopOperator I - Production (1st, 2nd and 3rd Shift)
This position is responsible for operating pharmaceutical packaging machines/equipment.
1st Shift - Monday - Friday 7:30 am to 3:30 pm
Packaging Operator - $15.00 per hour
Manufacturing Operator - 15.75 per hour
2nd Shift - Monday - Friday 3:15 pm to 11:15 pm
Packaging Operator - $15.00 per hour plus $1.25 per hour Shift Differential
3rd Shift - Sunday - Thursday 11:15 pm to 7:15 am
Packaging Operator - $15.00 per hour plus $2.50 per hour Shift Differential
Position Responsibilities: Assists in material handling, equipment set-up and breakdowns, documents process according to Master Production Records, and works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.
Position Requirements: This position requires a High School Diploma or equivalent, 1-2 years experience preferred. Must be 18 years or older. Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards. Must be able to read, comprehend and follow written and verbal instruction with accuracy. Must have the ability to read, comprehend and follow written and verbal procedures. Must have excellent accuracy/attention to detail. Must have good basic communication and interpersonal skills. Must be able to lift a minimum of 25 pounds. Understanding of GMP requirements is preferred and a plus.
Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts.
| Complete Online Application
| TopQuality Assurance Specialist I
This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements.
• Perform Packaging Line inspection/audits and provide assurance that packaging operations are compliant with applicable SOPs and GMPs
• Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
• Perform annual retain sample inspections and control finished product and raw material samples stored in the reserve sample room.
• Perform Complaint writing
• Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness.
• Bachelor’s degree and applicable pharmaceutical experience.
• 1 year experience working within a Pharmaceutical Quality Department.
• Ability to coordinate multiple tasks in a fast-paced environment
• Ability to read and follow procedures
• Ability to work independently
• Must have attention to detail
• Excellent Interpersonal skills
• Excellent organization and follow through skills
• Excellent written and verbal communication skills
• Knowledge of GMPs
• Must be able to work within a team environment
• Must have excellent computer skills
• Previous work in a regulated environment – Pharmaceutical preferred
• Troubleshooting/Problem solving Skills
| Complete Online Application
| TopSr. Scientist I - MPS
The Senior Scientist I – Marketed Product Support (MPS) independently leads technical projects as assigned by the head of Product Development. He/she is responsible for providing technical oversight and recommendations to support currently marketed products including but not limited to alternate materials, process improvements, investigations, and technology/site transfers.
Primarily responsible for managing technology transfer and other MPS projects while following good Manufacturing Practices (cGMPs):
• Authors and executes documents such as protocols, reports, batch records, and technical assessments.
• Plans/executes experiments and analyzes data. Records data in laboratory notebooks.
• Able to use statistics to plan experiments and analyze data (e.g. Design of Experiments, Statistical Process Control, Process Capability)
• Evaluates and/or proposes equipment purchases
• Tests/evaluates characteristics of new raw materials and/or packaging components
• Provides Manufacturing, Validation, Packaging, and Regulatory Affairs, with technical input.
• Assists in training operations on new products/processes.
• Provides technical input on investigations and/or CAPAs associated with manufacturing and packaging of marketed products.
• Proactively identifies manufacturing/packaging process improvements.
• Professionally interacts with third parties
Assists with improving department infrastructure and procedures. Helps to develop best practices related to MPS and/or technical writing.
Maintains department Standard Operating Procedures (SOPs). Initiates, creates, and revises SOP’s as appropriate.
Performs other duties as assigned or requested.
Education - Bachelors, Masters, or Ph.D. in Chemical Engineering, Chemistry, Biology, or a related science.
Experience - Minimum of 4 years with a Ph.D., minimum of 7 years with a Masters, minimum of 9 years with a Bachelors.
Must have the ability to coordinate multiple projects in a fast-paced environment. Must have demonstrated ability to perform in a team environment. Must have excellent communication skillls, organizational and follow-through skills and interpersonal skills. Other requirements include troubleshooting ability, understanding of GMPs, ability to plan, organize, implement, and product transfer projects, plans and objectives. Demonstrated leadership skills. Strong technical writing ability, Familiarity with FDA guidance related to Marketed Product Support (MPS) (e.g. SUPAC, Stability) Previous pharmaceuticals industry experience.Submit Resume
| Complete Online Application