Current Job Opening
Quality Assurance (QA) Manager or Director
Alfa Scientific is a manufacturer of medical diagnostic test kits for use in testing for Drugs of Abuse, Fertility, Infectious Diseases, Cardiovascular and Cancer Diagnostics. We now have an opening in our organization for a qualified QA Professional as either a QA Manager or Director depending on the candidates qualifications.
The Quality Assurance Manager is responsible for continuing the establishment of quality system for Alfa Scientific. He or she will implement and maintain the effectiveness of the existing Quality Systems and other compliance processes. These include: internal and external audits, management of the Product Complaint process and CAPA processes. The Manager/Director will coordinate inspections of the organization and contract facilities, and develop procedures to ensure regulatory compliance. The position leads and directs the work of other team members to include Regulatory Affairs, Document Control and Quality Control. Knowledge of IVDD requirements for In Vitro Diagnostic products is required.
- Continues developing and enhances Alfa Scientifics comprehensive quality system strategy and procedures, including establishing key metrics for measuring improvement, as well as monitoring and reporting methods for processes, trending, client satisfaction, goal setting and outcome.
Implements and maintains the effectiveness of the Quality System.
- Responsible for Design Control process to ensure that US FDA and ISO Quality System requirements are met on a consistent basis.
- Coordinates and be the primary interface for internal, external (customer, vendor, or manufacturer), and compliance (such as FDA, ISO) audits/inspections in accordance with regulatory standards. Responsible for follow-ups/corrective actions within specific timeframe.
- Ensures consistent levels of compliance, internally and externally when applied throughout development, manufacturing and distribution of Alfa Scientific products. This includes but not limited to formal documentation, vendor/manufacturing evaluation and qualification, on-site or off-site inspections and audits, deviation investigations, maintenance and calibration, customer complaint investigations, CAPA, and risk-analysis/management.
- Accountable for all QA program training and development, including driving the adoption of quality programs that bridge all functional teams.
- Be the focal point for all matters relating to Quality across Alfa Scientific and advocate across the company to raise awareness of the commitment to high quality standards and drive continual improvement.
- Identify and make recommendations for process and organizational changes related to quality control that lead to measurable improvements in quality, cost, and other variables.
- Facilitates continuous improvement efforts including identification of issues, root cause analysis, and correction of quality control problems.
- Write and/or revise controlled documents in support of job responsibilities.
- Ability to work independently in a fast paced small business environment.
Other duties as assigned.
- Bachelor’s degree in an applicable science or engineering plus at least five years IN-Vitro diagnostic, medical device, pharmaceutical or biotech industry experience in a Quality Assurance role.
- Prefer Certification in ISO 13485, ASQ, CQE, CQA, and/or RAC (RAPS).
- Knowledgeable with US regulations and International standards pertaining to medical device, specifically,
- GMP standards and regulations (21 CFR Part 820) and ISO 13485:2003
- Quality systems development, implementation and maintenance
- Process validation
- Vendor and process/systems auditing
- Risk analysis and management
- Document control and change management
- Evaluation of regulatory requirements and standards, and determining quality system impact and/or design requirements
- Basic computer literacy (e.g., MS Word, Excel, PowerPoint)
- Familiarity with quality software systems (e.g., complaint, document control, etc.)
- Experience in supporting US FDA and/or Notified Body inspections/audits (or other similar regulatory body inspections)
- Must be highly motivated, show initiative/independence, and be driven to make important contribution
- Logical and analytical problem solver, ability to troubleshoot issues and understand technical issues, and ability to demonstrate sound reasoning and judgment
- Excellent interpersonal, presentation, written and verbal communication skills with conflict resolution
- Ability to work in cross-functional teams
- Strong time management and organizational skills
- Ability to work independently as well as be part of a diverse team
- Ability to prioritize and multi-task, setting and meeting aggressive timelines
- Flexible with sense of urgency
Please send your resume, cover letter with salary history and requirements in confidence to: email@example.com or fax to 858-513-8388
Manufacturing Production Technician
Alfa Scientific Designs Inc. supplies high quality, novel diagnostic products worldwide to Drug Testing Facilities, Pain Clinics, the central laboratory, hospital and physician’s office marketplaces. Our San Diego facility employs staff in the manufacturing, product development, sales, marketing, regulatory, and distribution of Point Of Care Rapid Test products. We target the areas of Drugs of Abuse Tests, Fertility, Infectious Diseases, Cancer Markers and Cardiac Markers.
Include the following. Other duties may be assigned.
- Responsible for all activities associated with Clinical Diagnostic antibody preparation
- Formulate bulk reagents/buffers according to written procedures (MPR’s).
- Perform routine lab analysis.
- Reconcile documents and work orders.
- Support projects and design transfers with supervision.
- Meet daily production goals, labor use requirements, and work order closure.
- Ensure all documentation is maintained to remain compliant with all industry regulations (i.e. FDA, ISO, etc).
To perform the job successfully, an individual should demonstrate the following competencies :
Problem Solving – Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Interpersonal Skills – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
Oral Communication – Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification if needed
Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively; Able to read and interpret written information.
Organizational Support – Follows policies and procedures; Completes administrative tasks correctly and on time.
Motivation – Demonstrates persistence and overcomes obstacles.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Follows through on commitments.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
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 individuals with disabilities to perform the essential functions.
Education and/or Experience
Bachelors degree and 1-3 years previous commercial laboratory work experience. Analytical methodology, inventory control and validation experience required.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak English and Chinese or Korean a major benefit
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
To perform this job successfully, an individual should have knowledge of Internet software. Must be versed in Microsoft Office Suite (Word, Excel, Powerpoint, Outlook).
Job: Manufacturing Production Technician
Primary Location: United States-California-Poway
Job Type: Regular/Full Time
Please reply to firstname.lastname@example.org with a cover letter, your resume and your salary history and expectations.