QUALITY ASSURANCE SPECIALIST

• Issues Specification controls, Deviation Reports, NCR Reports, OOS Reports, or CAPAS as needed.
• Handles quality systems, including Batch logbooks, non-conformances, CAPAs, Deviations, OOSs, training, Skill matrix, and other quality system programs.
• Review SOPs and Quality Manual as needed.
• Approves or rejects all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.
• Review production records to ensure that no errors have occurred or, if errors have occurred, that they have been thoroughly investigated.
• Approves or rejects all procedures or specifications impacting the drug product's identity, strength, quality, and purity.
• Supports Document Control.
• Supports change control and customer complaints.

Major Responsibilities

• Leads the facility in adopting GMP and disciplined use of a defined, well-documented, and systematic process for implementing change into plant processes for new product launches and product process redesigns.
• Supports External Audits.
• Supports defining processes, tool identifications and selections, and training of quality Standards and processes.
• Inspect the finished product for accurate description, lot number, expiry date, etc.
• Reviews Control Documents.
• Review training records and investigating records.
• Be proactive and Staff Function and help prevent defects.
• Follows validation master plan for the entire system as prepared.
• Provide quality KPIs for the management meetings.
• Prepares Annual Product Review

Qualifications

• BS degree in chemistry, biology, microbiology, or any related field.
• Must have GMP education, training, and/or experience.
• Be able to comprehend Acorn’s environment of fast production and the need for Urgency in getting things done without compromising the quality of the product.
• Detail oriented, FDA regulations knowledge
• Proficient in Microsoft Word and Excel programs

Job Type: Full-time

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Experience level:

• 1 year
• 3 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Office

Work Location: In person