advanced quality technician, manufacturing quality assurance

Leading Pharmaceutical Manufacturer seeks MQA Technician at Portage Facility to develop, implement, and maintain quality systems supporting manufacturing operations.

Job Description

Partners with operations to lead in developing, implementing, and maintaining quality systems that support manufacturing operations to meet product and process quality metrics. Provides GMP oversight through guidance against health authority regulations. Performs product sampling and testing to support drug product manufacturing, troubleshoots quality issues, issues line-clearances, and facility releases.

• Provides GMP/GDP guidance to ensure proper actions and documentation occur within the manufacturing space.
• Performs AQL testing on finished products by verifying various attributes such as product appearance, product and packaging dimensions, presence and accuracy of printing on strip and pouch, and seal integrity.
• Performs line clearances for all steps of the manufacturing process.
• Reviews, assesses, and archives pest control documents.
• Performs QA retain sampling; conducts analysis and documentation of results.
• Spot checks and conducts facility walkthroughs for critical process steps to ensure adherence to policies, procedures, and regulations.
• Performs problem-solving/troubleshooting for incidents observed and initiates event reports for incident resolutions.
• Understands the manufacturing schedule and provides quality support to ensure business continuity.
• Ensures that the manufacturing environment is in a state of control by evaluating the building's automated system software.
• Conducts routine audits and walkthroughs to ensure audit readiness.
• Verifies schedule and workflow adherence.
• Communicates any non-conforming events to the Manufacturing Quality Associate and Operations Team Leads and management.
• Performs other duties as instructed by quality management.
• Leads and participates in special projects.
• Acknowledges that this position occasionally requires off-hours and weekend work to ensure adequate QA floor support while production is running.

Job Qualifications

• BS degree in chemistry, biochemistry, or related science field highly desired.
• 3 years of related experience in the pharmaceutical, biotechnology, or medical device industry with increasing responsibility preferred.
• Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
• Technical proficiency at reviewing/auditing production records, reports and/or GMP related documentation.
• Ability to work within a team environment and willingness to contribute to the overall goals of the company.
• Strong technical writing skills.
• Good problem-solving techniques and a demonstrated ability to troubleshoot.
• Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels both internally and externally.
• Experience working directly with regulatory agencies a plus.
• Owns a driver's license and can travel between production facilities as required.
• Must be willing to work off-hour shifts and weekends as necessary.

Physical Qualifications

• Can carry or lift up to 35lbs.
• Be able to pass vision and hearing tests as required.
• Can spend up to 65% of the shift working while standing or moving.