Job description

summary / objective
This role provides management oversite to the daily activities within the production department with a primary focus and responsibilities in providing oversite to batch record review, investigation, and deviations.

essential functions

• Ensure that staff adheres to all policies and procedures.
• Develops and maintains training curricula and files for the department.
• Conducts site annual GMP and Data Integrity Training.
• Serves as the Quality Systems subject-matter-expert (SME) for the Operations group.
• Ensures the Change Control, Deviation, CAPA, and Investigation Systems and all Quality events are managed as outlined per SOPs.
• Reviews and assesses all Quality events (CAPA, Deviations, Change Controls), including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending.
• Initiates and assigns Quality events (CAPA, Deviations, Change Controls, Investigations, etc.) as requested.
• Ensures Quality events as progressed through the system for manufacturing and packaging.
• Performs investigations as required.

· Works directly with internal cross-functional areas.

· Develops and issues Quality metrics.

· Supports Operations to guide various projects and technical meetings, as needed.

· Assists the internal audit program.

· Supports customer and regulatory audits.

· Executed and writes manufacturing and packaging investigations and deviations.

· Writes and approves SOPs. This role ensures and maintains the organization compliance withFood and Drug Administration (FDA) 21 CFR part 4, 11, 210, 211, and 820 compliances.

· Demonstrates an ability to monitor and report on assigned tasks, goals, and objectives.

· Performs other tasks as assigned.

work environment

This job operates in a professional office environment, business casual/casual attire required. Occasionally, this role requires visits and access to both the manufacturing and packaging environments where appropriate Personal Protective Equipment (PPE) is mandated. This role requires the use of standard office equipment such as computers, phones, photocopiers, and fax machines.

physical demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee may be required to sit at a computer or be on your feet for long periods of time and/or periodically be on their feet for long periods of time. This job requires the need to be able to lift a maximum of twenty (20) pounds.

position type/expected hours of work
This is a full-time position. Days and hours of work are Monday through Friday, 7:00am to 3:30pm. Extended (earlier or later) work times or weekend work may be required. Some flexibility in times may be coordinated with approval of the department manager.

management responsibilities

Provides management and oversight to the manufacturing and packaging staff.

required education and experience

• Bachelor’s degree required preferably in the areas of science or technology (i.e. chemistry, micro-biology, biology, engineering, etc.)
• Five (5) or more years of prior experience working in pharmaceutical manufacturing environment, preferably in Quality Assurance or Quality Control
• Must have experience/knowledge of drug substance/product/finished product manufacturing processes in a cGMP environment
• Experience working with contract manufacturing organizations
• Ability to exercise judgment with defined procedures and practices to determine appropriate action
• Exceptional knowledge of pharmaceutical regulations (i.e. 21 CFR Parts 4, 11, 210 and 211 as well as 820)
• Excellent written and oral communication skills
• Computer literate with working knowledge of Microsoft Office applications
• Demonstrated ability to plan and work independently with a demonstrated ability to execute tasks and logical plan for task execution and follow-up
• Demonstrates a systematic approach to problem solving and troubleshooting
• Demonstrated high level to detail and organization in task management

preferred education and experience

· Same as above

· American Society of Quality (ASQ) – CQA certification

work authorization/security clearance (if applicable)

· Authorized to work in the United States

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• pharmaceutical manufacturing: 3 years (Required)

Language:

• English (Required)

Work Location: One location

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