Job description

The QA Technician I performs quality assurance functions specific to material disposition to ensure continuous production in accordance with established procedures, guidelines and standards at the Bangor, PA facility. This position will be responsible for the execution of Quality Assurance activity including but not limited to the review and disposition of raw materials, components, and finished goods while ensuring good manufacturing practices are followed throughout the facility.

Essential Duties and Responsibilities:

• Issues batch records and analytical summary sheets for all products packaged at BioSpectra’s Bangor, PA facility.
• Reviews and approves Batch Records including all documentation review associated with the release of the manufactured product.
• Issues or approves Certificate of Analysis for Finished Goods Shipments.
• Issues, and assists with discrepancy investigations.
• Performs preprocess room inspection as needed.
• Communicates any quality related requirements or findings to applicable department staff to ensure the correction or prevention of non-conforming events.
• Reviews deviations in the production process and discusses deviations with Quality Assurance Manager, Production Management and supervisors.
• Performs Finished Good Inspection or QA Approval prior to Finished Good Shipments.
• Performs Finished Good Inspection Final Review upon completion of Finished Good Shipments.
• Reviews and Approves Preventative Maintenance documentation.
• Reviews and Approves Maintenance Work Orders.
• Inspects or approves incoming Components and Raw Materials.
• Approves and monitors the usage of controlled inventory in Sage ERP system.
• Provides the placards detailing the disposition of material for placement in the facility Warehouses.
• Recommends modifications of existing quality or production standards to achieve optimum quality within limits of manufacturing capability.
• Confirms the quality availability of products scheduled for shipments and provides product dates/shipping.
• Ensures Quality records are accurate, approved and in compliance with cGMP standards.
• Ensures that the facility is functioning in accordance with established quality policies and procedures through document review and approval, quality walkthroughs, communication with personnel and training support.
• Other duties may be assigned as deemed appropriate by management.

Qualifications:

• Associate’s Degree in Life Science, Biology or a related field, with at least 3 years of experience or documented equivalent experience.
• Thorough knowledge of cGMPs
• Knowledge of relevant software applications including MS Office
• Knowledge of office systems and procedures
• Competent keyboard skills
• Organized, Thorough, Neat
• Communication skills – written and verbal
• Confidentiality
• Must be able to read, write, speak, and understand English

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Ability to see and distinguish color
• Bend, stoop, and carry
• Repeating motion that may include wrists, hands, and fingers

Work Hours:

• Non-Exempt Position
• Minimum of 8 Hour Shift (7am to 3:30pm), 5 Days a Week, or other agreed upon documented schedule
• Ability and willingness to work from all BioSpectra facilities

Job Type: Full-time

Pay: From $21.00 per hour

Schedule:

• 8 hour shift

Work Location: One location

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