Principal Manufacturing Associate - 2nd Shift

We’re seeking a motivated individual capable of providing on the floor leadership to a team of 6-8 manufacturing associates to produce pharmaceutical components and products by following current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) within a cleanroom environment. You will be expected to demonstrate expertise and breadth of knowledge in executing process recipes across a variety of production activities, following written procedures (SOPs), monitoring equipment and processes, independently performing laboratory tasks, including pH, conductivity testing, product sampling, and conducting routine sanitization tasks to maintain facility and equipment and train other operators on these tasks.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Demonstrate expertise and technical leadership in operations and cGMP compliance.
• Run the operations in an effective efficient manner, utilizing visual methods to represent real time status.
• Drive a manufacturing schedule to deliver quality product on time, right first time to maintain supply to patients.
• Ensure the suite is production ready with all materials, documentation, trained resource, and equipment ready for operations.
• Excellent understanding of process flow and the factors which influence changes in the operation.
• Troubleshoot complex and non-routine equipment, operational and process events.
• Make decisions based on safety, quality, GMP and technical operations experience.
• Develop an in-depth expertise within the team of associates for all activities performed for production, focus on the why in addition to the what and how during training. Train other personnel on equipment operation, cGMPs, documentation, technical theory, or other tasks. Maintain individual training plan.
• Lead by example to engrain a strong safety culture within the team which is evidenced in behaviors and presentation of the area.
• Highly focus on a safe work environment and continuous improvement on safety.
• Develop and maintain a strong quality culture within the team and production area.
• Ensure good documentation practices are followed by all employees during GMP production.
• Be respected by peers and possess motivational skills to maintain high morale within team.
• Initiate and investigate deviations
• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.
• Ensure microbial control standards are maintained in the production area.
• Lead shift exchange and represent manufacturing at meetings pertaining to ongoing production.
• Participate in projects to improve the production area
• Present the production area overview to inspectors during regulatory audit tours
• Lift up-to 20-50lbs.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree with 3+ years’ of experience in GMP manufacturing production
• OR, Associates Degree in life sciences or H.S./Equivalent and biotech certificate, with 4+ years’ of experience in GMP manufacturing production
• OR, High School Diploma or Equivalent with 4+ years of experience in GMP manufacturing Production and 6+ months of GSK manufacturing experience.
• OR, High School Diploma or Equivalent with 5+ years of experience in GMP manufacturing Production.

Preferred Qualifications:

• Knowledge of cGMP, GDP, USP, and FDA quality guidelines and regulations preferred.
• The ability to comprehend process flow and identify factors which influence the process.
• The ability to think critically and creatively; discusses changes, progress, and issues as they relate to other functional areas
• The capability to solve moderately complex problems; exercise judgement and identify innovative solutions; considers relative value of several alternative solutions to potential issues before making a recommendation to the path forward. 
• Author and owner of SOPs and policies, work independently on complex manufacturing tasks, identify, and communicate non-routine events, and review more complex decisions with Supervisors.
• The ability to use automated process equipment and tools.
• Experience with leading and directing a team preferred.
• The ability to recognize opportunities for improvements with t