Quality System Specialist - Batch Record Review

The Quality Systems Specialist for Batch Record Review and Product Release will ensure that all company policies follow the Regulatory Agencies, which are effectively executed per regulations and company policies. This person has a strong attention to detail, excellent organizational skills, and experience working in a GMP-regulated industry.

Duties/Responsibilities:

• Support and improve a Quality Systems system that meets GMP requirements.

• Ensure that all Standard Operating Procedures and Master Batch Records follow the cGMP and in accord with business needs.

• Manage release of commercial lots, review Batch Records after execution. Identify issues and support correction process.

• Collaborate with cross-functional teams.

• Support audits and inspections by ensuring all documents are readily available and organized.

• Support investigations of deviations and root cause analysis for events on packaging process.

• Develop and implement CAPA from events or investigations or as a result of an audit from a client or health agency.

• Seek continuous improvement opportunities to enhance the Quality of Systems

• Other tasks as assigned by the supervisor.

Required Skills/Abilities:

• Bachelor’s degree or equivalent work experience in a related field

• 3+ years of experience in Quality Systems in a GMP-regulated industry

• Knowledge of GMP regulations and documentation requirements

• Knowledge of electronic document management systems (QCBD)

• Excellent organizational and time management skills

• Strong attention to detail and accuracy

• Ability to work both independently and as part of a team.

• Exceptional interpersonal and communication skills

• Proficient in MS Office applications

Work Environment/Work Conditions:

• Office/manufacturing work environment

Job Type: Full-time

Pay: From $18.00 per hour

Expected hours: No less than 40 per week

Benefits:

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

Experience level:

• 3 years

Schedule:

• 10 hour shift

Work setting:

• In-person
• Manufacturing facility

Application Question(s):

• What are your pay expectations?
• Do you have knowledge of GMP regulations and documentation requirements?

Education:

• Bachelor's (Preferred)

Experience:

• Quality Systems: 3 years (Preferred)

Ability to Commute:

• Wixom, MI (Required)

Work Location: In person