West Pharma BPR Reviewer Molding 

United States, Arizona, Tempe 

835785445

Job Summary:

Ensures that manufactured goods are produced to critical quality parameters by reviewing batch production record documentation. Performs batch production release based on the results of documentation review. Ensures that all reviewed records conform to the requirements of Good Documentation Practices, and that records reflect a commitment to current Good Manufacturing Practices.

Essential Duties and Responsibilities:

• Review batch production records to ensure compliance to all internal and external key quality attributes.
• Document, record and file batch production records on completion.
• Ensure the quality release of production batches is performed appropriately and expediently.
• Communicate review results to Production and Quality management in a timely manner.
• Report recurring quality and/or documentation issues to relevant personnel, supervisors, and management in a respectful and collaborative manner.
• Assists shift employees with identified quality issues.
• Contribute to continuous improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
• Provides a ‘Customer Services’ attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.

Basic Qualifications:

• Education or Equivalent Experience: High School or equivalent

• Experience: 0-3 years of experience
• Must be proficient in English language (verbal and written)
• ISO regulations and standards

Preferred Knowledge, Skills and Abilities:

• Vocational, technical training or degree with emphasis in Quality Control
• Experience working in manufacturing environment
• Experience working in medical device or other regulated industry

Travel Requirements:

Physical & Mental Requirements:

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources.
• Maintain company and customer confidentiality at all times.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Use hands/fingers to handle or feel or operate objects, tools or controls and reach with hands and arms.
• Must transport oneself to and from other areas of the facility and travel to other divisions when necessary.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Must be able to maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Learn and apply new information or new skills
• Must be able to understand direction and adhere to established procedures.
• Must be able to effectively communicate in/understand the English language in verbal and written form.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• May be required to lift heavy objects up to 25lbs without assistance.