POSITION SUMMARY
The primary responsibility of the Quality Assurance (QA) Specialist is to work with a number of Quality Systems ensuring compliance is maintained to meet the current Regulatory requirements. The Quality Systems are Deviation Management, Non-Conforming Materials, CAPA, and Customer Complaints. The QA Specialist is responsible for product quality by evaluating various processes against validated methods and licensed parameters, while ensuring timely product release. Will interface with multiple departments to ensure successful results. The position will support regulatory reporting and communications as required. Other responsibilities will include individual and group projects to support Quality Assurance initiatives across the company.
ESSENTIAL DUTIES & RESPONSIBILITIES
- Investigate and report as required, issues identified under the deviation management system including database management.
- Focus on thorough investigations, sound root causes, meaningful corrective actions and identify areas where deviation reoccurrence could be avoided.
- Work with various departments in the development of effective corrective and preventative actions. Follow up for effectiveness evaluation and database management.
- Investigate and report on customer complaints and administer the customer complaint database. Interface with various departments to investigate and ensure timely resolution of complaints. Report both to the investigation file and to the customer.
- Responsible for timely completion of the quarterly product review and other periodic reports as required.
- Coordinate and manage investigations relating to trend analysis or problem areas requiring investigation utilizing multiple resources.
- Assist in the closure of Out of Tolerance events, processing of Facilities Change Requests and the review of Documentation Change Requests.
- Perform housekeeping inspections of manufacturing areas, report issues to area management, and ensure closure of all inspection findings.
- Support regulatory submissions and responses as required.
- Provide scientific and / or technical advice and counsel regarding projects as needed.
- Participate in departmental and cross functional team meetings and / or assemble cross functional teams and / or facilitate team meetings as necessary.
- Maintain current knowledge of regulatory and industry standards.
- Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
- Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
- Strict adherence to procedures and practices according to FDA regulations.
- Strong emphasis on documentation according to FDA regulations.
- Adhere to departmental corporate safety policies.
REQUIRED EXPERIENCE/SKILLS & EDUCATIONAL QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
- Bachelor’s degree in Biology, Chemistry, Microbiology, Biochemistry or closely related scientific / technical discipline is required.
- Minimum of 2 years of experience in a pharmaceutical, GMP, or FDA regulated environment is required. Direct experience in Quality Assurance, Quality Operations, Quality Control or Quality Engineering function is preferred.
- Requires a basic understanding of pharmaceutical manufacturing, aseptic processing, laboratory processes and Quality Assurance / Operations. Knowledge or background in Quality systems and theory is preferred.
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
- Experience in conducting investigations is preferred.
- Must have strong technical writing skills.
- Ability to work independently with minimum supervision.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Must be proactive, results oriented, and have strong attention to detail.
- Self-starter with strong work ethic and the ability to exercise good judgment.
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
- Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
- Excellent verbal and written communication skills in the English language.
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
PHYSICAL REQUIREMENTS
- Ability to lift /move up to 25 pounds.
- Ability to sit/stand for extended periods - up to four (4) hours at a time.
- Manual dexterity to perform all job functions.
- Ability to gown and work in an aseptic/clean room environment.
- Exposure to toxic/caustic chemicals and biological hazards.
