Manufacturing Associate II (FT) 23201

Headhunters, LLC is seeking a Manufacturing Associate to ensure deviations/CAPAs are timely addressed and closed relating to manufacturing/technical operations for the Fill and Finish Facility. Work closely with department subject matter experts (SMEs) to obtain pertinent information necessary to write/close deviations, providing expertise on necessary preventive measures, and to ensure site deviation metric is within a controlled state. Individual will be the SME for defending relevant deviations in GMP audits (internal and external) . Individual will lead and coordinate effort for continuous improvement in deviation reductions for the site.

Responsibilities

-Authoring and resolution of Deviations, Change Controls, CAPAs and additional documents in order to support production needs and meet product release requirements.

-Deviations – utilize root cause analysis techniques during the investigation process and work cross functionally to help implement effective preventative actions and perform thorough product impact analysis. -Write complete and accurate deviations. Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure.

-CAPA/CC– Writes CAPAs & CC’s in order to meet production release requirements and support continuous improvement needs and operational optimization. Identify appropriate CAPA implementation and/or effectiveness checks

-Additional Documents - Collaborate with Technical Writers to write, review, revise and/or prepare manufacturing documents (BPR, SOP, SWI, etc.) in accordance with cGMP and regulatory guidelines.

-Independently analyze complex issues using risk appropriate decision making

-Demonstrated technical writing ability; capable of interpreting and citing specific procedures as it applies to investigation decision making and timely closures.

Initiate tracking and follow up of more complex issues stemming from deviation investigations

-Assist in the continuous reduction in generation of deviations by helping to implement effective preventative actions.

-Identification and facilitation of interdepartmental continuous process improvements.

Education, Experience & Skills

Bachelor’s Degree in Science and/or a minimum of 3-5 years of technical writing experience in the pharmaceutical/biotechnology discipline. This is an exempt (salary) position.

Physical/Mental Requirements

Expertly write technical deviations relating to manufacturing process with the following skills:

-Working knowledge of cGMP's

-Organized; great technical writing ability

-Good investigational & problem solving skills

-Good interpersonal skills and ability to work in a team environment.

-Working knowledge of root cause analysis

-Knowledge of continuous improvement techniques

-Ability to work extended and flexible hours (including weekends) when needed

Please email your resume and cover letter to Meredith: Meredith@headhuntersllc.org