Mqa Associate-2Nd Shift

MQA Associate-1st shift

Job Summary:

This role provides Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption.

Responsibilities:

· Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.

· Perform Acceptable Quality Limit (AQL) visual inspection of drug product.

· Review and approve batch documents for media and buffer prep solutions.

· Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP’s.

· Compile deviations as required when observed on the floor and move to completion within the required time frame.

· Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product – 70% of day is spent on the floor.

· Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices

· Identify and implement and continuous improvement initiatives. Participate in site and corporate quality and process improvement initiatives.

· Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements, and industry best practices.

· Other duties as assigned.

Qualifications:

· High School Diploma Required; Bachelor’s degree -STEM Sciences preferred, or equivalent experience

· At least a 2 years’ experience within the biologic, biopharmaceutical, or regulated industry.

· 2 Years’ experience in Manufacturing/Quality Assurance/Quality Control function preferred.

· Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.

· Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish.

Physical Requirements:

· Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors. May be given a visual exam for visual acuity and color perception.

· Must communicate fluently in English and have legible handwriting.

· Ability to travel between and within facilities to visit staff, operations, projects, etc.

· Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

· Ability to lift up to 30 pounds regularly.

· May require up to 5% travel, based on business need

Job Type: Full-time

Pay: $25.00 - $34.00 per hour

Benefits:

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

Experience level:

• 2 years

Schedule:

• Day shift

Work setting:

• In-person
• Manufacturing facility

Work Location: In person