Manufacturing Specialist

Location: Bogart, GA

This is what you will do:

The Manufacturing Specialist provides cross-functional support with responsibilities for supporting commercial manufacturing operations performed in the Transgenic Manufacturing Network.  The role will include troubleshooting and continuously improving the manufacturing processes at Alexion’s Transgenic Operations with a focus on Quality System records management, deviation investigation lead, and Standard Operating Procedure revisions.  This role will include participating in cross functional teams and multitasking several projects at one time.

The position requires leadership of manufacturing investigations working with Quality Assurance, Quality Control, Technical Services, Engineering, Facilities/Maintenance, Logistics, Training, Validation, and CMC/Regulatory.  Success will be measured by (1) timely completion of all investigations, (2) quality of investigation write-ups, and (3) development and execution of effective CAPAs.

You will be responsible for:

• Lead manufacturing investigations, including root cause analysis and product impact assessment.

• Support CAPA development and execution.

• Provide support for manufacturing change control development and execution.

• Author and revise manufacturing standard operating procedures.

• Provide support to Egg White Harvest and Protein Production Unit operations as needed.

You will need to have:

• BA/BS degree is required.

• And a minimum of 2-years experience in a GMP biotech/ pharmaceutical manufacturing environment or have a significant level of relevant work experience to ensure the immediate support of the manufacturing team.

• Must be competent in Microsoft Word and Excel

• Must be able to use complex electronic systems such as SAP and TrackWise

• Must have the capacity to develop in-depth knowledge of manufacturing operations and various quality systems

• Technical problem-solving skills

• Knowledge of current Good Manufacturing Practices (GMPs) and regulatory requirements

• Exceptional verbal and written communication skills

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• 4+ years of experience in a GMP biotech/ pharmaceutical manufacturing environment or have a significant level of relevant work experience to ensure the immediate support of the manufacturing team.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.