Employment Opportunities at Avanti

Avanti offers a creative and professional environment where people succeed. At Avanti we hire smart people, give them the tools they need, and get out of their way and let them work. As a result, many of our unique products were created by team members that are passionate about what they do.

Avanti was founded with one driving vision–the pursuit of perfection. At Avanti excellence is expected and rewarded; communication is open and straightforward. We strive every day to maintain an atmosphere that promotes growth and employee satisfaction.

Positions Available

Chromatography Specialists
Quality Assurance Associate
Senior Quality Assurance Associate
Rotary Evaporation Technicians

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Chromatography Specialists

Chromatography Specialists are responsible for the purification of GMP and R&D products. The primary duties of a Chromatography Specialists include but are not limited to:

  • Processing of separate, individual batches of product (GMP and R&D). (Individual batches must be processed separately and cannot be mixed.)
  • Accurate mixture of elution solvents.
  • Performing Thin Layer Chromatography.
  • Performing Gravimetric Analysis.
  • Building, conditioning and tearing down glass columns.
  • Equipment calibration, maintenance and cleaning (stainless steel columns, pumping systems, etc.).
  • Cleaning glassware.
  • Cleaning and maintaining glass syringes.
  • Other duties that may be assigned relevant to the position.

Requirements:

  • High school diploma; some college preferred.
  • Background in chemistry a plus.
  • Strong math skills required.
  • Good problem solving skills.
  • Good verbal and written communication skills.
  • Must be able to lift 50 pounds.

Send resume to jobs@avantilipids.com.  Please reference job applying for in subject line.

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Quality Assurance Associate

Avanti Polar Lipids, Inc. is seeking a Quality Assurance Associate for its pharmaceutical manufacturing operations. This position will be responsible for ensuring compliance with the U.S. Food and Drug Administration’s Good Manufacturing Practices.

Responsibilities will include but not be limited to the following:

  • Perform Document Control for Batch Production Records (BPRs), Standard Operating Procedures (SOPs), Raw Material (RM), Avanti Product (AP) specifications and Job Descriptions.
  • Conduct product releases / rejections including review of batch production documents, review of analytical results, comparison to specifications).
  • Implement and follow the Corrective and Preventive Action Program (CAPA) process to ensure effective and timely closure of CAPAs.
  • Perform Facility / Equipment qualification.
  • Conduct Annual Product Review.
  • Provide QA input for product shipments including product release, label preparation, review and application, final label review, shipment packaging, and shipment documents.
  • Write and revise BPRs, SOPs, RM specs, AP specs and Job Descriptions.
  • Perform annual document reviews as required by quality systems.
  • Perform internal audits.
  • Conduct raw material qualification.
  • Prepare and assist Regulatory Affairs during customer / FDA audits.
  • Review / Approve Out-of-Specification (OOS) documentation.
  • Perform Change Control (review and approval of Deviations and Change Requests).
  • Perform process / method validation program (including design and review of validation efforts).
  • Develop and deliver high quality and high impact training programs and services that provide functional, GMP and product knowledge to employees.

Requirements:                                                                                                                                          

  • S. degree in science, engineering or business management.
  • 3 years’ experience in quality or operations, primarily in a cGMP environment.
  • Working knowledge of FDA regulations.
  • Pharmaceutical operations experience and/or knowledge required.
  • Effective written and verbal communications skills required.
  • Task and detail oriented.
  • Possess good critical thinking skills.
  • Proficient in Microsoft Office Suite.

Send resume to jobs@avantilipids.com.  Please reference job applying for in subject line.

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Senior Quality Assurance Associate

Avanti Polar Lipids, Inc. is seeking a Senior Quality Assurance Associate for its pharmaceutical manufacturing operations. This position will develop and support key metrics and analysis. The Senior QA Associate will have responsibility for CAPA oversight to ensure effective and timely closure of CAPAs.  The position will also design and conduct training to meet compliance goals, development needs and support operational excellence initiatives.

Responsibilities include but are not limited to the following:

Quality Metrics and Trending

  • Generate quality metrics using specific systems/applications, developing quality monitoring database and creating appropriate level reports using MS Excel or other software (MasterControl).
  • Conduct analysis to determine causes of poor performance.
  • Assess causes systemically, looking beyond the obvious to determine why people, processes and/or systems are not meeting quality standards.
  • Analyze resulting quality metrics and assess trends.
  • Work with supervisors of departments to ensure consistency and close gaps in coaching and training.
  • Provide ongoing analysis of data resulting from the quality systems review and communicate analysis to management.

CAPA Oversight

  • Implement, track and trend CAPA program requirements to ensure effective and timely closure of CAPAs.
  • Facilitate CAPA meetings to allow assigned CAPA owners to have the appropriate visibility to the status of CAPAs to ensure timely closure.
  • Gather data, analyze, and communicate metrics related to the CAPA quality system during management quality review.
  • Conduct training for the use of the MasterControl CAPA Management System.
  • Collaborate with IT to resolve issues and implement enhancements.
  • Review and approve low level investigations and CAPAs as assigned by the QA Manager.
  • Review and approve status reports and effectiveness check records as assigned for active CAPAs.

GMP Trainer

  • Design, develop and deliver high quality and high impact training programs and services for employees to achieve a high level of performance in their jobs.
  • Collaborate across functional areas to develop employee job training requirements and assist in development of training materials and knowledge assessments, for area SOPs.
  • Prepare training session plans and documentation to be presented; Lead group training sessions and conduct follow up to determine applicability of course material.
  • Develop and maintain training performance metrics and continuously evaluate the effectiveness of training programs; track status of compliance to training requirements and report to management.
  • Conduct training for the use of the MasterControl Training program module, providing training/support to system users. Collaborate with IT to resolve issues and implement enhancements.
  • Maintain current expertise in applicable regulatory authority requirements and current industry expectations for employee training.

Requirements:

  • S. degree in science, engineering or business management.
  • 7 years’ experience in quality or operations, primarily in a cGMP environment.
  • Good working knowledge of FDA regulations.
  • Prior CAPA/Investigation oversight experience
  • Pharmaceutical operations experience and/or knowledge required.
  • Experience in collecting, analyzing, and presenting data.
  • Experience in developing metrics, reporting and analysis.
  • Effective written and verbal communications skills required.
  • Task oriented.
  • Demonstrated technical/analytical skills and attention to detail.
  • Possess good critical thinking skills.
  • Proficient in Microsoft Office Excel using pivot tables, charts, graphs, etc.) or other software (MasterControl).

Send resume to jobs@avantilipids.com.  Please reference job applying for in subject line.

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Rotary Evaporation Technicians

ROTARY EVAPORATION TECHNICIANS support the manufacturing and production process for GMP and R&D products. This position is responsible for the efficient and gentle removal of solvents from pharmaceutical products by evaporation using rotary evaporators. The primary duties of a Rotary Evaporation Technician include but are not limited to the:

  • Assembly and disassembly of rotary evaporators (large and small).
  • Processing of separate, individual batches of product (GMP and R&D). (Individual batches must be processed separately and cannot be mixed.)
  • Equipment calibration, maintenance and cleaning.
  • Use of lyophilization systems and vacuum ovens.
  • Installation, replacement and use of compressed gas cylinders.
  • Cleaning glassware.
  • Other duties that may be assigned relevant to the position.

Requirements:

The ideal candidate will have a high school diploma, be mechanically inclined and be able to prioritize work. Prior experience in a cGMP manufacturing environment helpful. Good verbal and written communication skills required. Must be able to lift 50 pounds and be able to stand for long periods.

Send resume to jobs@avantilipids.com. Please reference job applying for in subject line.

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Ready To Join The Team?

Send your resume to jobs@avantilipids.com or fax it to (205) 663-0756 or (800) 229-1004.

Avanti Polar Lipids, Inc. is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to jobs@avantilipids.com or call (205) 663-2494 to let us know the nature of your request.

Avanti Polar Lipids, Inc. has been manufacturing the highest quality phospholipids, sphingolipids and sterols for the research and pharmaceutical industry for 47 years. We have a unique reputation for purity that is achieved by our highly trained team of over 100 employees working together to ensure the quality of the final product.

Avanti is located in Alabaster, Alabama, a suburb 20 minutes south of Birmingham. We offer a creative and professional environment where people can succeed. Avanti was founded with one driving vision—the pursuit of perfection. At Avanti excellence is expected and rewarded. We strive to maintain an atmosphere that promotes growth and employee satisfaction.

Avanti Polar Lipids, Inc. is an equal employment / affirmative action employer.