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Quality Assurance Specialist (10am - 7pm)

SCA Pharmaceuticals

Quality Assurance Specialist (10am - 7pm)

Windsor, CT
Full Time
Paid
  • Responsibilities

    SUMMARY:                                                                                                                   

    The Quality Assurance Specialist is responsible for performing Quality Assurance (QA) oversight of GMP compounding and support activities at SCA Pharmaceuticals. The Quality Assurance Specialist assists system owners in performance of non-conformance investigations, assists in the review and execution of CAPAs, stability protocols, risk assessments, as well as reviews and approves all Quality Events for the site. The Quality Assurance Specialist II also supports technical change control activities, label, product and raw material specifications. This position requires advanced understanding of site processes in order to write and review technical documents including engineering studies and standard operating procedures.

    The position is a non-management position. The individual occupying it is expected to be capable of working with minimal supervision. The Quality Assurance Specialist is expected to communicate well with fellow Quality Assurance employees as well as Operations and Quality Control departments.

    ESSENTIAL FUNCTIONS:

    • Conduct evaluations and process audits of production personnel to ensure procedures are being followed in accordance with GMP compliance and Standard Operating Procedures (SOPs)
    • Provide guidance, as requested, to production employees with the intent to foster understanding and compliance with SOPs, GMPs and process improvements
    • Provide input and decision making for quality on the shop floor with regard to manufacturing deviations and provide corrective actions as necessary
    • Review and approve Quality Events including; Deviations (DVs), Out of Limits (OOLs), Out of Trends (OOTs and CMS events), Laboratory Event Investigations (LEIs)
    • Author, review and/or approve technical documents for the site including standard operating procedures, visual displays, technical qualifications, investigations, technical change controls, and corrective and preventative action plans and effectiveness checks
    • Review and approve specifications for labels and finished products
    • Review process variability reports, stability protocols and stability reports
    • Review and approve master batch records
    • Perform data analysis, identify corrective/preventative actions, process deviations and investigation reports
    • Perform inspection and release of incoming raw materials
    • Assist with complaint investigations as part of QA investigations
    • Assist in the coaching and training of employees for required Quality Assurance related initial and annual cGMP and GDP training
    • Review and evaluate production batch records and QC data for release, as required
    • Performs other duties as assigned

    SUCCESSFUL CANDIDATES WILL HAVE:

    • Detail oriented and strong organization skills with the ability to provide strategic and improvement recommendations/solutions
    • Ability to multitask efficiently and identify roadblocks prior to project milestones
    • Strong communication skills driving organizational engagement
    • Ability to be flexible in a fast-paced environment
    • Ability to work independently with minimal supervision and collaboratively with cross functional teams
    • Proficiency in the use of a personal computer with expertise in Microsoft Word, Excel, and PowerPoint
    • Candidates must be able to accommodate shift schedule. Shifts may include routine weekend and evening work as required by the business needs
    • Candidates must be able to accommodate unplanned overtime (occasional weekends) on little to no prior notice
    • This position is for the 10am to 7pm shift, however there could be room for flexibility

    SUPERVISORY RESPONSIBILITIES

    • This position will not have any supervisory responsibilities however will lead/direct others in all matters of quality assurance.

    • Work Environment

    • This position often works in all areas of our production/manufacturing areas while being involved in quality matters and inspections. Proper protective equipment will be worn at all times, including being completely “garbed up” as needed

    PHYSICAL DEMANDS

    • Sitting, standing and walking often throughout all areas
    • Reaching with hands/arms
    • Bending and reaching in hard to access areas

    QUALIFICATIONS:

    Knowledge: Familiarity with regulatory requirements for a 503B Compounding Outsourcing Facility, or applicable experience in sterile pharmaceutical, medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP preferred

    Skills: Leadership, critical thinking, decision-making, effective communication

    • Minimum Education: 4-year degree in life sciences, engineering, or related discipline.
    • Preferred: 2-5 years of quality experience in pharmaceutical, medical device or other related industries preferred

    SCA Pharmaceuticals is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.