Job description

Essential Functions
If starting position is in incoming laboratory and in-process inspections:

• Performs area clearances/line clearances, in-process inspections of manufacturing processes, and inspection and disposition of incoming material.
• Monitors manufacturing process performance as relates to SPC/SQC, general compliance status of manufacturing and warehouse areas, as well as ensures components, product or equipment under evaluation or not in compliance is properly controlled.
• Prepares and attaches material quality status on materials, including labeling.
• Performs the verification of all labels after final printing is completed.
• Executes assigned activities in accordance with production schedule and participates in production schedule planning, as needed.
• Assists in the development, implementation, and maintenance of site quality procedures, standards, and controls.
• Supports the quality audit function through occasional conduct of investigations of nonconformances or deviations and assists with corrective actions and preventative actions associated with site quality.
• Performs other tasks related to the assurance that product meets established standards for quality and efficacy as assigned by supervisor.
• Performs special projects as assigned by supervisor to meet company and departmental goals.

OR

If starting position is in analytical laboratories:

• Performs chemical analysis of raw material, in-process materials, finished drug product, stability, validation, and R&D samples in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements within the Quality Control Laboratory at the Port Allen, LA manufacturing facility.
• Performs the collection, handling, and documentation of raw materials, chemical reagents, laboratory standards, and sample vessels (handle and move compressed gas cylinders) in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
• Performs the calibration and preventative maintenance of analytical instruments in accordance with OSHA, EPA, FDA, cGMP, and other appropriate regulatory requirements.
• Reviews other analysts’ work.
• Performs routine housekeeping activities; create and submit HOLD alerts, work orders, etc. as applicable.
• Performs special projects as assigned by supervisor to meet company and departmental goals.

Minimum Requirements

Education / Experience / Skills:

• Associate’s Degree in technical or scientific related field required
• Bachelor’s Degree (preferably in a science related field) preferred
• Experience in a regulated work environment is preferred
• Quality certificate preferred (ASQ CQE, CQA, etc.)

Competencies:

• Understand and internalize drug cGMPs, OSHA, EPA, and FDA regulations/requirements as related to drug and medical device manufacturing.
• Proficient in Word and Excel.
• Mathematical skills
• Mechanical aptitude
• Excellent oral and written communication skills; interpersonal skills; and organizational skills.
• Detailed-oriented.
• Excellent team ethic and practice.
• Collaborative, tactful, and able to communicate with various levels in the organization.
• Assertive in enforcing regulations, policies, and procedures.
• Basic knowledge of laboratory analyzers and inspection equipment used to perform chemical analyses and component inspections.

Job Type: Full-time

Salary: From $24.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Port Allen, LA 70767: Reliably commute or planning to relocate before starting work (Required)

Education:

• Associate (Required)

Experience:

• Quality inspection: 1 year (Required)

Work Location: One location

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