This position is responsible for executing Prolacta’s manufacturing processes and operation systems while strictly adhering to current Good Manufacturing Practices (cGMP’s), Environmental Health & Safety guidelines, and other regulations that apply. The activities include but not limit to issuing production picklist, batch records review and accuracy, performing investigation for non-conformances, identifying corrective actions.  Manufacturing Associate is a key support position to ensure a smooth operation and adherence to the production schedule.  This position will also be involved in many process improvement projects related to the operation systems.

Primary Duties and Responsibilities

·         Lead simple non-conformance investigation writing and resolution, including developing effective corrective actions. 

·         Lead simple corrective actions from idea to completion including effectiveness monitoring.

·         Issue document change control to update manufacturing document which include but is not limited to batch records and Standard Operating Procedures (SOP’s). 

·         Perform manufacturing document review and lead Good Documentation Practice (GDP) improvement efforts.

·         Finished product mock label creation and label printing subject matter expert

·         Post and adjust manufacturing results for manufacturing in-process and finished product to inventory control system

      ·         Work closely with Quality and Manufacturing personnel to resolve manufacturing challenges including equipment OOT.

·         Improve First Time Success rate for manufacturing operation (reduction of non-conformance occurrence in operation).

·         Assist manufacturing in Lean implementation which includes 5S, cell layout and improvement, one-piece flow transition, visual management, cycle time reduction, etc.

·         Reporting Manufacturing metrics to plant scorecard and own gap analysis and improvement plan.

Job Requirements and Qualifications

Requirements

12 months of work experience in manufacturing operation, prefer to have previous Manufacturing or Quality Associate experience.

Qualifications

·         Good writing and oral skills

·         Proficient at computer usage including MS Office (Word, Excel, PowerPoint, Access and Visio preferred)

·         Ability to quickly learn new software including off-the-shelf label printing software or quality system management software, and in-house developed inventory control software.

·         Familiar with bar code control systems

·         Quick to adapt to technology changes including use of tablets or mobile devices.

·         High School Diploma required, bachelor’s degree preferred

Other Knowledge, Skills and Abilities

Team/Collaboration

Consistently takes the initiative to work with others. Changes interpersonal style and approach based on circumstance or audience. Good team spirit, positive attitude. Shows a willingness to work effectively with others.

Communication Skills; Critical Thinking

Consults the appropriate resources to obtain information and shows good judgment on when to escalate a problem or issue.  Able to assess a problem or situation using effective logic.  Uses important information to make logical assessments. 

Accepting Direction

Accepts and follows directions from leads/management; respects authority; complies with request; does what they are asked to do.

Accountability

Takes full responsibility for actions and does not make excuses. Understands and exhibits behavior of thinking beyond their role on the team and ensures team’s success beyond their individual contribution. Performs to required standard, owns mistakes and uses them as opportunities for learning and development.  Flexes as needed. Accepts constructive feedback and/or consequences without making excuses or blaming others first.

Work Environment (Location, travel, shift, on-call, etc.)

Travel

<5%

Location

City of Industry, Infrequent Work at Duarte