Center Quality Assurance Supervisor at Shelby
2 months ago
Center Quality Assurance Supervisor at Shelby
Shelby
Who Are We?
Powered by technology and compassionate design, Parachute has reimagined the plasma donation experience into one that is easier and friendlier. Using a simple app, our members can book donations and track earnings from the palm of their hand. In using a tech-forward approach, we’re able to offer each member a highly personable and best-in-class experience that’s consistent at each and every visit.
Our vision is to introduce an elevated plasma donation experience that’s grounded in convenience to markets with smaller populations. This model allows us to positively impact the industry supply chain and help patients gain access to the medication they need.
Come join us as we help the world gain access to more plasma - one donation at a time.
What You’ll Do
The Center Quality Assurance Supervisor is responsible for managing the quality assurance operations of the Donor Center and supervising operations and quality control, while ensuring compliance with all applicable policies and regulations.
Responsibilities
Lead and direct overall Donor Center quality compliance by ensuring the center is audit ready at all times and is compliant with industry regulations, government regulations, and with standard operating procedures.
Work with the Center Director to maintain product quality, integrity, and safety; donor suitability and safety; and employee safety.
Ensure that product meets all regulatory and customer requirements.
Maintain an independent level of quality inspection and control.
Participate in all formal regulatory audits with the Center Director and quality team and develop effective corrective action plans, as needed. The Center Quality Director will liaise directly with auditors and ensure that all required quality tasks are completed within required time frames.
Oversee release of product and shipment of product to vendor and ensure that shipment meets all regulatory and customer guidelines.
Oversee product and biohazard waste shipments by doing the following: ensure shipments meet regulatory specifications and product release requirements, ensure accurate labeling and documentation, and authorize final shipment.
Work with the Center Director to determine donor suitability and manage donor deferrals, as needed.
Work jointly with the Center Director and trainers to develop employee knowledge that personnel performance is critical to the purity, safety, and integrity of the product.
Track industry trends and implement process improvement plans. Measure and determine effectiveness of said plans and adjust when needed.
Ensure compliance with all federal, local, state, and company regulations related to quality of product, employee, and donor safety.
Partner with the Center Director and training personnel to review the SOP and applicable forms to ensure that they are always current and ensure that employees are trained on any updates to SOP.
Hire, lead, develop, and manage Quality Assurance team .
Who Are You?
A natural leader.
Enthusiastic, energetic, warm, and personable.
Able to multitask, set priorities, and work under tight deadlines.
Extremely organized, process-driven, and detail-oriented.
Exceptional oral and written communication skills. Ability to express ideas and give direction clearly and swiftly.
Technically proficient.
Exceptional interpersonal skills.
Excellent leadership skills. Prior experience managing a team of direct reports and the ability to effectively delegate, train, and provide constructive feedback is preferred.
An ability to put customers at ease and foster Parachute’s friendly, supportive, and “member-centric” approach. While you will not necessarily be the first point of contact for donors, there may be situations where you will need to interact with and assist donors. Ensuring that all donors have a positive experience from start to finish is essential.
Requirements
A bachelor’s degree in Biological Science, Business Administration, Nursing, Finance, or a related field or equivalent experience.
At least 3 years of experience in a cGMP environment with plasma or whole blood experience or equivalent experience in a clinical or general business setting.
Proficiency with Microsoft Office Suite (Word, Excel)
Ability to travel by plane and/or car on occasion
Physical: Able to stoop, kneel, crouch, reach, pull, and lift a minimum of 50 lbs. Ability to sit or stand for extended periods of time.
Auditory and visual acuity.
Required to enter an environment (with suitable cold environment outerwear) with a temperature of -40°C for short periods of time.
Ability to work day and evening hours, weekends, holidays and extended shifts as needed.
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