Job description

The Quality Manager is responsible for creating and implementing policies and procedures for the successful execution of BioDevelopment’s Quality System. This position is responsible for management of all Quality Assurance and Quality Control activities, staff, and documentation performed at BioDevelopment Inc. to ensure compliance with regulatory guidelines and industry standards. This position is also responsible for the quality disposition of all incoming raw materials and components as well as the release of all finished goods.

Major Roles & Responsibilities:

• Authors, reviews, and approves procedures and documents pertaining to any document that impacts product quality.
• Manages the change control program to ensure changes to procedures, systems and processes are documented, approved, and implemented in accordance with BioDevelopment policies, industry standard and regulatory expectation.
• Ensures all Process Validation and Qualification Activity is compliant with BioDevelopment Master Plan and quality standards.
• Reviews and approves of all process validation and qualification from development through validation and qualification reports.
• Confirms the quality availability of products scheduled for shipments
• Provides Management and Commercial team dates for product release.
• Ensures Quality records are accurate, approved, and compliant with cGMP standards.
• Ensures all Quality activity complies with BioDevelopment Inc. Policies, ICH Q7 and applicable Regulatory Standards.
• Completes Quality Activity within MasterControl as Quality and Department Approval for BioDevelopment Inc.
• Ensures that Computer System Validations are compliant to BioDevelopment Policies, ICH Q7, and applicable regulations.
• Ensures all BioDevelopment Inc. quality expectations align with executed Customer Quality Agreements.
• Completes all Commercial Requests related to Quality.
• Reviews and approves all product labels.
• Hosts all Quality and Regulatory Audits.
• Ensures data retention and records are stored in accordance with BioDevelopment Inc. Policies.
• Ensures BioDevelopment Inc. documents are reviewed and approved in a timely manner.
• Provides the necessary documents for Regulatory compilation.
• Ensures issued CAPAs for the Quality group are completed and implemented in a timely manner or as directed.
• Performs Quality Inspections.
• Manages the Complaint Program and creates customer response as required.
• Communicates deviations of the production process, documentation and/or records to Production Manager and supervisors and provides guidance for the appropriate correct and preventive actions in response to the deviations.
• Issues Laboratory Investigations.
• Issues Discrepancy Investigation.
• Reviews and approves discrepancy investigations.
• Approves Quality Control Investigations
• Reviews and approves Preventative Maintenance documentation and Maintenance Work Order Request Forms.
• Authors and/or approves Certificates of Analysis and issues certificates as required.
• Manages site specific change control program and prepares notification as required.
• Manages and implements the temporary operating instructions to be issued for quality activities.
• Manages the review and approval of Batch Records including all documentation review associated with the release of manufactured product.
• Manages all quality activity for raw materials and components received and product release in Sage.
• Supports the completion of all required regulatory activities for BioDevelopment Inc.
• Managers Quality Control Staff and assignments for material analysis.
• Other duties as assigned.

Qualifications:

• 4-Year scientific degree or equivalent experience in a cGMP environment
• Thorough knowledge of cGMP & ICH-Q7
• Ability to effectively present information to management and other groups
• Knowledge of relevant software applications including MS Office and Minitab
• Organized, Thorough, Neat
• Must be able to read, write, speak, and understand English
• Confidentiality
• Ability and willingness to work and travel from all BioSpectra facilities

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Repeating motion that may include wrists, hands, and fingers

Job Type: Full-time

Pay: From $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Rensselaer, NY 12144: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Minitab: 1 year (Required)
• Microsoft Office: 1 year (Required)
• CGMP: 4 years (Required)

Work Location: One location

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