QA Associate

OVERVIEW:

CMIC CMO USA is seeking a hands-on QA Associate to provide Quality Assurance support on the manufacturing, packaging, and warehouse floors in a cGMP contract pharmaceutical environment. This role involves real-time batch record review, sampling, in-process checks, material release, and support of quality systems to ensure compliance with FDA and industry standards.

MAJOR RESPONSIBILITIES:

• Provide QA oversight during manufacturing and packaging operations.
• Perform sampling of raw materials, packaging components, water, gas, in-process and finished product samples, and environmental monitoring.
• Collect cleaning samples (TOC, drug active, micro swabs) and submit to QC with documentation.
• Perform room and equipment clearance prior to batch operations.
• Conduct in-process testing and AQL checks during manufacturing and packaging.
• Receive and log external samples into internal quality systems.
• Support document control activities including issuance, training records, and archival.
• Release raw materials, packaging components, in-process and finished products.
• Review executed batch records, warehouse receiving logs, logbooks, and forms.
• Assist in preparation and review of quality documentation including SOPs, forms, deviations, investigations, CAPAs, and change controls.
• Review documentation supporting warehouse, metrology, engineering, and validation to ensure completeness and cGMP compliance.
• Provide QA floor support for manufacturing, packaging, laboratory, and warehouse operations.
• Collaborate cross-functionally to address and resolve quality issues.
• Train new employees on QA procedures and GMP documentation practices.
• Ensure adherence to GMP, GDP, and company policies.
• Perform other duties as assigned by the supervisor or QA Director.

QUALIFICATIONS

• Bachelor's degree preferred (Life Sciences or related field)
• Experience in Quality Assurance within a cGMP-regulated environment preferred
• Experience with controlled documents or QMS systems strongly preferred
• Excellent communication (verbal and written) and interpersonal skills with ability to interact with people at all levels of the internal and external organization.

Skills:

• Strong written and verbal communication skills
• Ability to multi-task and work independently with minimal supervision
• Detail-oriented with strong organizational and time-management abilities
• Proficient in MS Word, Excel, and basic spreadsheet tools
• Ability to work collaboratively across departments

Physical Requirements

• Ability to stand and walk on production floor for extended periods
• Ability to sit at a computer for extended periods
• Ability to lift up to 25 lbs occasionally

Job Type: Full-time

Pay: $ $24.00 per hour

Benefits:

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

Work Location: In person