Performs and documents the packaging operations for pharmaceutical products in accordance with Noven Pharmaceuticals Inc. SOPs and cGMPs. Works closely with cell team to identify and reduce waste in processes to optimize efficiencies and drive down operating expenses.

• Ensure the manufacturing of high quality pharmaceutical products per production schedule within established SOP that are made with multiplicity of materials and assembled on a high-speed highly automated production line.
• Ensures all shift documentation, including electronic batch records adhere to FDA Regulations, cGMP, GDP and SOP requirements.
• Adheres to safety policies and promotes a safe work environment by recognizing safety hazards.
• Performs all equipment/tooling change-over, set-ups and adjustments for equipment of responsibility in a safe and effective manner per defined work standards.
• Accurately inspects, measures and documents critical tooling to ensure it meets production criteria.
• Ensure all components are loaded and staged correctly and accurately.
• Keep all equipment in top working condition to avoid breakdowns and delays in manufacturing processes.
• Performs preventive maintenance, general maintenance and report spare parts needs to ensure maximum equipment uptime.
• Perform in-process test of manufactured product to ensure compliance with quality standards and drive quality at the source
• Performs daily verification of calibrated equipment.
• Reconciles in-process components and performs accountability of all materials used.
• Maintains cleanliness of area and adhere to company 6S program standards.
• Participates in cell team meetings to discuss day-to-day performance metrics and provide input on product quality, equipment deficiencies and operational excellence.
• Prepares daily shift performance reports
• Work proactively together with other cell team and value stream members to achieve regular, incremental improvements in equipment operation.
• Strict adherence to attendance and timeliness policies.
• Trains new employees on safety, quality, production procedures and equipment performance.
• Foster a team environment founded on Noven Pharmaceuticals Inc. mission, values and leadership principals.
• Troubleshoot equipment problems and escalates technical issues as required.
• Utilize a variety of software systems to support daily work activities (i.e. MES, Blue Mountain RAM, MS Excel, MS Word, MS Outlook, Machine Interface)

Qualifications

Competencies:

• Judgment:Must possess the ability to ascertain that work and documentation complies with approved GMP standards and company regulations.
• Written and Oral Communication:Must possess the ability to express oneself clearly in writing, conversations and interactions with others.
• Fostering Teamwork:Must possess the ability and desire to work cooperatively with others on a team.
• Managing Change:Must possess the ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness; initiating, sponsoring, and implementing organizational change; helping others to successfully manage organizational change.
• Initiative:Must possess the ability to identify what needs to be done and doing it before being asked.
• Detail Oriented:Must be able to pay attention to details. Ensuring that one’s own and others’ work and information are complete and accurate.

Education & Experience:

• Technical Associate Degree, or equivalent technical education and/or experience in a cGMP environment.
• Ability to speak, read and write in English language
• Candidate must demonstrate mechanical aptitude
• Basic computer skills and ability to perform basic mathematical calculations.
• Able to establish and maintain effective working relationships.
• Minimum of 1 year experience working with the CMPL Equipment

Work Environment:

Manufacturing floor environment.  Pharmaceutical products.

Ability to work overtime as required.

Physical Demands:

Often required to stand for up to an hour at a time with stooping and bending.  Visual acuity and manual dexterity required to perform essential duties.  The employee must be able to l