Kindeva Drug Delivery
Manufacturing Quality Assurance Specialist II - 2nd Shift
Kindeva Drug Delivery, Lexington, Kentucky, us, 40598
Manufacturing Quality Assurance Specialist II - 2nd Shift
Join to apply for the
Manufacturing Quality Assurance Specialist II - 2nd Shift
role at
Kindeva Drug Delivery
Overview Our Work Matters. At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: Responsible for on-shift support of manufacturing operations, providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing. Also responsible for review of cGMP documentation and manufacturing records, including deviations or Out-of-Specification (OOS) results. Participates in the release of raw materials, intermediates, and final products. Performs internal and external audits of facilities and products, observes critical operations, audits documentation, and keeps management informed on quality issues.
Responsibilities
Supports on-shift manufacturing operations and activities including real-time auditing of production batch records, sampling and Acceptable Quality Levels (AQLs), and line clearances.
Supports the development and maintenance of Quality Systems as appropriate.
Leads continuous improvement objectives to assure compliance with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations.
Advises senior management on findings and recommendations related to internal and external auditing.
Manages deviation, Out-of-Specification (OOS), Corrective and Preventive Action (CAPA), and Change Control Systems.
Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards. Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
Reviews and approves cGMP documentation, including procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
Develops and maintains metrics and trending reports for Compliance-related activities.
Reviews and approves product complaint investigations and assists with investigations.
Performs activities associated with various one-time or ongoing projects (from participation level to project manager).
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (GxP, 21 CFR Part 11, etc.).
Supports regulatory inspections and customer audits. Assists the Manager with daily and project activities as needed.
Performs other duties as assigned.
Qualifications
Bachelor's degree in a scientific discipline. At least 3 years of experience in Pharmaceutical/Medical Device cGMP quality.
Knowledge of ALCOA+ data integrity principles and compliance with 21 CFR Part 11 for electronic records.
Knowledge of HPLC principles and ability to review data for accuracy and completeness.
Knowledge of microbiological testing principles and ability to review data for accuracy and completeness.
Ability to assess problems, identify solutions, plan and implement changes.
Experience in quality systems auditing (internal and/or external) preferred.
Familiarity with electronic Quality Management System (QMS) platforms (e.g., TrackWise, MasterControl).
Experience in manufacturing aseptically filled, sterile products preferred.
Advanced knowledge of cGMP regulations and validation principles (FDA 21 CFR Part 820, ISO 13485).
Ability to work well in a team-oriented environment.
Well-developed communication and technical writing skills.
Qualified to work with controlled substances.
Experience in leading and assisting deviation investigations and CAPA implementation.
Physical Requirements
Specific vision requirements include close vision, distance vision, color vision, and ability to read/understand/execute documentation.
Employees are required to follow all current cGMP and safety procedures.
Regular use of hands to handle materials and supplies.
Effective communication by telephone and electronic means.
Regular standing and walking for extended periods.
Wear all required safety equipment and perform work safely.
Use proper lifting techniques and be conscious of hazards.
Must follow GMP and safety procedures within the department.
Occasionally lift and/or move up to 25 pounds.
California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Equal Opportunity Employer statement.
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Pharmaceutical Manufacturing
We’re uninterrupted in sharing updates with our community. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
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Manufacturing Quality Assurance Specialist II - 2nd Shift
role at
Kindeva Drug Delivery
Overview Our Work Matters. At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: Responsible for on-shift support of manufacturing operations, providing quality involvement and oversight during all stages of pharmaceutical development, manufacturing, and testing. Also responsible for review of cGMP documentation and manufacturing records, including deviations or Out-of-Specification (OOS) results. Participates in the release of raw materials, intermediates, and final products. Performs internal and external audits of facilities and products, observes critical operations, audits documentation, and keeps management informed on quality issues.
Responsibilities
Supports on-shift manufacturing operations and activities including real-time auditing of production batch records, sampling and Acceptable Quality Levels (AQLs), and line clearances.
Supports the development and maintenance of Quality Systems as appropriate.
Leads continuous improvement objectives to assure compliance with Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations.
Advises senior management on findings and recommendations related to internal and external auditing.
Manages deviation, Out-of-Specification (OOS), Corrective and Preventive Action (CAPA), and Change Control Systems.
Evaluates proposed changes to processes, equipment, materials, or documentation to ensure compliance with regulatory and quality standards. Participates in investigations and root cause analyses for deviations, OOS results, and audit findings.
Ensures timely implementation and effectiveness checks of CAPAs to prevent recurrence of quality issues.
Reviews and approves cGMP documentation, including procedures, batch records, validation protocols, development reports, specifications, raw data, executed batch records, material and batch disposition, and other related documents.
Develops and maintains metrics and trending reports for Compliance-related activities.
Reviews and approves product complaint investigations and assists with investigations.
Performs activities associated with various one-time or ongoing projects (from participation level to project manager).
Collaborates with departments and external suppliers regarding quality concerns.
Participates and/or coordinates Compliance Assessments of departments as necessary (GxP, 21 CFR Part 11, etc.).
Supports regulatory inspections and customer audits. Assists the Manager with daily and project activities as needed.
Performs other duties as assigned.
Qualifications
Bachelor's degree in a scientific discipline. At least 3 years of experience in Pharmaceutical/Medical Device cGMP quality.
Knowledge of ALCOA+ data integrity principles and compliance with 21 CFR Part 11 for electronic records.
Knowledge of HPLC principles and ability to review data for accuracy and completeness.
Knowledge of microbiological testing principles and ability to review data for accuracy and completeness.
Ability to assess problems, identify solutions, plan and implement changes.
Experience in quality systems auditing (internal and/or external) preferred.
Familiarity with electronic Quality Management System (QMS) platforms (e.g., TrackWise, MasterControl).
Experience in manufacturing aseptically filled, sterile products preferred.
Advanced knowledge of cGMP regulations and validation principles (FDA 21 CFR Part 820, ISO 13485).
Ability to work well in a team-oriented environment.
Well-developed communication and technical writing skills.
Qualified to work with controlled substances.
Experience in leading and assisting deviation investigations and CAPA implementation.
Physical Requirements
Specific vision requirements include close vision, distance vision, color vision, and ability to read/understand/execute documentation.
Employees are required to follow all current cGMP and safety procedures.
Regular use of hands to handle materials and supplies.
Effective communication by telephone and electronic means.
Regular standing and walking for extended periods.
Wear all required safety equipment and perform work safely.
Use proper lifting techniques and be conscious of hazards.
Must follow GMP and safety procedures within the department.
Occasionally lift and/or move up to 25 pounds.
California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Equal Opportunity Employer statement.
Seniority level Mid-Senior level
Employment type Full-time
Job function Management and Manufacturing
Industries Pharmaceutical Manufacturing
We’re uninterrupted in sharing updates with our community. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr