Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Are you ready to Join Parachute? We are bringing digital innovation to the plasma industry to find new donors and give people access to the medication they need!
Ready to take the leap from a QA Associate to Management?
You're in luck. We are looking for a Quality Assurance Manager to join our Quality Unit. You are the right person for the job if you have:
2 years experience in the biologics industry.
Ability to lead a team and effectively communicate with all levels of the organization.
Want to work at in a fast-paced and technology-enabled environment and have the ability to oversee and prioritize the Quality System.
Want to be an early employee in a high-growth company with significant opportunity for career advancement.
Think about new approaches to old problems.
The expectation is that you will:
Work under the Center Quality Director to ensure the purity and efficacy of the plasma and the safety of donors and employees.
Maintain internal audit perspective to ensure the Donor Center is in compliance with Standard Operating Procedures (SOPs) and applicable Food and Drug Administration (FDA) regulations, European Medicines Agency (EMA) regulations, Clinical Laboratory Improvement Amendments (CLIA) regulations, Plasma Protein Therapeutics Association (PPTA) requirements, customer requirements, state regulations, and Good Manufacturing Practices (GMP).
Maintain an independent level of quality inspection and control.
Work with Center Quality Director to maintain product quality, product integrity in all processes, donor suitability, and safety of donated product.
Work with the Center Quality Director to determine donor suitability and manage donor deferrals as appropriate.
Work with trainers to perform observations in operational areas to make sure staff is following SOP.
Implement best practices from key performance indicators as part of the Center Quality Assurance team.
Engage in all formal regulatory audits with the Center Quality Assurance team to develop effective corrective action plans to address any areas of deficiency noted during audits.
Participate in responses to auditors.
Oversee release of product and shipment of product to customer.
Ensure that shipment meets all regulatory and customer guidelines.
Oversee product and biohazard waste shipments: ensure shipments meet regulatory specifications and product release requirements; ensure accurate labeling and documentation and authorize final shipment.
Review documentation of all unsuitable unit disposition and maintain documentation of process. Review lookback information and notification to customer.
Track industry trends and use Root Cause Methodology to develop a Corrective Action Preventative Action (CAPA) system and process improvement plans. Measure and determine effectiveness of said plans and adjust when needed.
Complete other duties as may be assigned from time to time by management.
The education requirements are the following:
Graduation from an accredited college with a bachelor’s degree, preferably in Science, Business, Nursing, Finance, or related field is required. Equivalent combination of education, training, and experience as described in Job Expectations and Essential Functions may be substituted for bachelor’s degree.
The experience requirements are the following:
Two (2) years of experience in a Good Manufacturing Practices (GMP) environment with plasma or whole blood experience preferred but may also review candidate with related experience in a clinical or general business setting. Supervisory experience preferred but not required.
You are expected to have the following knowledge and abilities:
Knowledge of modern health care concepts.
Knowledge of the legal aspects of plasma donor center documentation and decisions.
Knowledge of the principles of management, supervision and/or health care administration.
Knowledge of effective interviewing techniques in the plasma donor center hiring process.
Knowledge of federal and state health and safety regulations after a period of training.
Knowledge of the preparation and maintenance of accurate quality assurance and other records.
Ability to physically lift, move and position donors as needed.
Ability to develop innovative concepts and to apply them to program coordination and cooperation.
Ability to work effectively with representatives of various state and federal organizations and maintain a cooperative working relationship.
Ability to interpret and apply necessary rules, regulations, and policies and the utilization thereof in the development and implementation of staff training programs.
Ability to give suitable assignments and instructions.
Ability to work harmoniously with associates.
Ability to develop suitable work schedules for assigned employees.
Ability to handle, dispense, direct the use of and keep record of equipment, medications, and other supplies.
Must have high ethical standards, aptitude for statistical analysis and commitment to quality and compliance.
Must be proficient with computers.
Strong time management abilities and ability to prioritize and multi-task.
Ability to pass drug and TB screening and testing.
Ability to work under pressure; meet inflexible deadlines; set priorities; deal diplomatically with difficult individuals; supervise others; ability to manage multiple programs; lead management teams and work independently. Adherence to the highest ethical standards is essential.
Ability to keep clear, sound, accurate and informative reports containing findings and conclusions.
Ability to prepare detailed correspondence in the course of official duties.
Ability to establish and maintain essential records and files.
Ability to direct the maintenance of suitable records and files.
Ability to read, write, speak, understand or communicate in English sufficiently to perform the duties of this position.
Persons with mental or physical disabilities are eligible as long as they can perform the essential functions of the job after reasonable accommodation is made to their known limitations. If the accommodation cannot be made because it would cause the employer undue hardship, such persons may not be eligible.
The environmental conditions are as follows:
Plasma facilities are open to the public. Work environment may involve exposure to noise, dust, fumes, dangerous machinery, chemicals, body fluids, falling objects, and aggressive verbal and physical behavior from donors. Work environment includes working in extreme temperatures (i.e. -40°) while wearing proper cold environment outerwear.
The physical requirements and work environment are as follows:
Talking: ability to express and exchange ideas via spoken word, sometimes quickly and loudly.
Hearing and Vision: ability to perceive the nature of sounds with no less than 40 dB loss at Hz, 1000 Hz and 2000 Hz with or without correction. Ability to receive detailed information through oral communication. Work requires a minimum standard of visual acuity with or without correction that will enable employees to complete clerical tasks.
Dexterity: ability to stoop, kneel, crouch, reach, push, pull, lift, grasp, and be able to perceive the attributes of an object such as size, shape, and temperature. Movements are frequently and regularly required using wrists, hands and/or fingers.
Physical Strength: ability to lift up to 50 pounds using proper lifting technique. Position is mainly sedentary work (office work) but may on occasion include physical force execution.
Language: ability to write complex sentences, using proper punctuation, and ability to communicate in complex sentences using normal word order with present and past tenses.
Processing and Reasoning: ability to exercise self-control in potentially volatile situations such as in verbal and physical confrontations. Must be able to work and concentrate amidst distractions and noise.
Job Type: Full-time
Pay: $55,000.00 per year
Benefits:
Schedule:
Experience:
Ability to Relocate:
Work Location: In person
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