SUMMARY / OBJECTIVE

The QA Specialist I plays a key role in ensuring the integrity, compliance, and timely release of products within the organization. This position supports daily activities within the Batch Release department by reviewing and approving batch-related documentation, maintaining training records, and issuing manufacturing and packaging batch records in alignment with production schedules.

ESSENTIAL FUNCTIONS

• Ensures individual training is maintained and documented.
• Works directly with internal cross-functional areas.
• Issues Manufacturing and Packaging Batch Records to Production in alignment with the production schedule.
• Review and approve raw material and Events Data Summaries.
• This role ensures and maintains the organization's compliance with the Food and Drug Administration. Administration (FDA) 21 CFR Parts 4, 11,210,211, and 820 compliance.
• Ability to monitor and report on assigned tasks, goals, and objectives.

• Perform other tasks as assigned.

REQUIRED SKILLS/ABILITIES

• Simple math.
• Attention to detail.
• Good organizational skills.
• Ability to recognize and solve problems.
• Time management ability to handle multiple concurrent projects.
• Dependable.
• Excellent written and oral communication skills.

REQUIRED EDUCATION AND EXPERIENCE

• High School diploma or equivalent.
• 3-4 years (minimum) of experience working in a cGMP pharmaceutical manufacturing environment.
• Must have experience/knowledge of drug product manufacturing processes in a cGMP environment.
• Ability to exercise judgment with defined procedures and practices to determine appropriate action.
• Knowledge of pharmaceutical regulations (i.e., 21 CFR Parts 4, 11,210, and 211, as well as 820).
• Computer literate with working knowledge of Microsoft Office applications.
• Demonstrated ability to plan and work independently, with a demonstrated ability to execute tasks and a logical plan for task execution & follow-up.
• Demonstrated a high level of detail and organization in task management.

preferred education and experience

• Associate degree is preferred, preferably in the areas of science or technology (i.e., chemistry, microbiology, biology, engineering, etc.)

• Experience working with QA / manufacturing organizations or equivalent is highly desired.

position type/expected hours of work
This is a full-time position. Core work hours are Monday through Friday, 8 a.m. to 4:30 p.m. Extended work times (earlier or later) and weekend work are required as needed. Some flexibility in times may be coordinated with the approval of the department manager.

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 will be required to sit at a computer for long periods of time and/or periodically be on their feet for long periods of time.

work environment

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 will be required to sit at a computer for long periods of time and/or periodically be on their feet for long periods of time.