Address
Form of work
Salary- 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
