PharmaLex is hiring: Specialist Manufacturing in Juncos

Join to apply for the Specialist Manufacturing role at PharmaLex. The position is available for a fixed term contract at Juncos, PR and supports the manufacturing operations of one of Cencora’s partners.

Job Overview

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.
• Ensure that all non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system root cause analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.
• May participate in regulatory inspections.
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owner on CCRB packages impacting the process.
• Participate on the assessment or implementation of special projects or initiatives.

Education and Experience

• Doctorate degree OR Master’s degree and 3 years of Manufacturing Operations experience
• Bachelor’s degree and 5 years of Manufacturing Operations experience
• Associate’s degree and 10 years of Manufacturing Operations experience
• High school diploma / GED and 12 years of Manufacturing Operations experience

Preferred Qualifications

• Experience writing SOP, experience in equipment/process, create new SOPs and provide training to manufacturing personnel.

Skills

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Participate and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

Benefits

Compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to medical, dental, vision, and comprehensive wellness programs, the role includes paid parental leave, paid caregiver leave, and training and professional development resources.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. Harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.

Affiliated Companies

Echo Consulting Group Inc