Key Responsibilities:

• Review complex or high-risk production records for GMP compliance.

• Collaborate with cross-functional teams (Manufacturing, QC) to ensure timely batch release.

• Provide guidance and on-the-job training for new technicians.

• Assist in preparation for regulatory and client audits.

• Lead initiatives to streamline batch review and electronic systems.

• Follows all job-related safety and other training requirements.

Education

• High School diploma / equivalent minimally required.

• Associates degree or higher in Science or Technology is preferred

Experience

• Required: Minimum of 2 years of work experience in QA or QC or related field

• Required: Experience in a cGMP environment

• Equivalent combinations of education, training, and meaningful work experience may be considered

Knowledge, Skills, Abilities

• Strong understanding of cGMP and batch documentation flow.

• Good verbal/written communication skills to partner with production teams.

• Excels in a team environment.

• Basic math skills.

• Attention to detail while maintaining quality.

• Ability to follow SOPs.

Physical Requirements/Work Environment

• Use Personal Protective Equipment (PPE) and understand chemical hygiene.

• Infrequently lift and manipulate up to 50 pounds max unassisted.

• Stand and move about including reaching, bending, stooping, grasping.

• Use hand tools and equipment including forceful gripping, grasping, pushing and pulling.

• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.