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Operations Quality Assurance Specialist

SCA Pharmaceuticals

Operations Quality Assurance Specialist

Windsor, CT
Full Time
Paid
  • Responsibilities

    SUMMARY:                                                                                                                   

    The Manufacturing (Operations) Quality Assurance (MQA) Specialist is responsible for ensuring correct implementation of all operations, including but not limited to label/log generation, material picking and sanitization, sterile compounding, cleaning/sanitization of the aseptic areas, sampling of finished product, inspection, labeling and packaging, warehouse and shipping processes; microbiological testing; and chemical analytical testing.

    This position reports to the Quality Assurance Manager.  This position will have the authority to assesses GMP areas, aseptic technique and the adherence to SOP of the compounding technicians and pharmacists during compounding activities. This position will also assess all production support areas to ensure adherence to SOP. In addition, this position will assist with questions, concerns, and non-conformances as they occur inside and outside the cleanroom. This position is also responsible for batch record review and final product disposition, overseeing and coordinating Clean Room fit/finish inspections, QA oversight during process simulation trials/media fills and overseeing and coordinating gowning qualifications.

    The MQA Specialist is expected to be capable of working with minimal supervision as they oversee all areas of operations. This position is expected to communicate well with all levels of the organization.  

    THIS IS A 2ND SHIFT POSITION: 2PM - 11PM. 

    ESSENTIAL FUNCTIONS:

    Production Support

    • Be present in the cleanroom as well as during label/log generation, material picking and sanitization, inspection, labeling and packaging, warehouse and shipping processes; microbiological testing; and chemical analytical testing, to observe and ensure adherence to SOPs and proper aseptic techniques (as applicable)
    • Perform assessments during operations activities to ensure all work is performed in compliance with GMP, SOP and regulatory requirements
    • Provide feedback to Operations Department; document observations and track resolutions.
    • Review cleanroom and supporting area documentation for accuracy and contemporaneous completion in batch records and logbooks
    • Maintain gowning certification, enabling access to the cleanroom.
    • Respond to questions, concerns, and non-conformances related to all operations areas

    Batch Record Review and Product disposition

    • Review executed batch records
    • Proactively perform follow up on outstanding issues to ensure timely batch disposition
    • Effectively disposition (release or reject) a batch ensuring compliance with regulatory and internal requirements
    • Generate and approve SCA Certificate of Compliance

    Other Activities

    • Assist with management of the Gowning Qualification Program; maintain requalification schedule and oversee gowning applicating during qualification activities

    • Support Validation Department and provide QA oversight during Media Fills

    • Participate in and coordinate Clean Room fit/finish inspections

    • Support Facilities and Validation Departments during shut-down activities

    • Assist Operations Department with the investigation of deviations/non-conformances by providing guidance and support to in root cause determination and reviewing the impact and criticality of the event with respect to product function, quality, effectiveness, safety, reliability and customer satisfaction

    • Assist with the aseptic and GMP training for department's new hires and current employees, as required.

    • Evaluates SCA SOPs, Batch Records and checklists for compliance with cGMPs, cGDPs, and consistency with other SCA policies and procedures

    • Assisting in the development and the updating of SCA SOPs for compliance with cGMPs and consistency with other SCA policies and procedures

    • Represents SCA in a professional manner, at all times

    SUCCESSFUL CANDIDATES WILL:

    • Have effective communication and interpersonal skills across all functions within the organization
    • Possess knowledge of aseptic technique
    • MS Word, Excel, and PowerPoint experience is necessary
    • Knowledge and understanding of cGMP
    • Possess the ability to handle sensitive and extensive confidential data
    • Work independently and be self-motivated
    • Work well in a team/group setting
    • Possess strong organizational skills

    WORK ENVIRONMENT

    • • This job operates in a production/manufacturing environment. Proper protective equipment is worn at all times.

    PHYSICAL DEMANDS

    • Must be able to sit or stand for 5+ hours at a time, as needed
    • Must be able to gown in sterile coveralls, hood, goggles, boots, and gloves.

    QUALIFICATIONS:

    • Minimum of 2 years working experience in a cGMP pharmaceutical manufacturing facility.
    • Associates degree or Bachelor's degree from an accredited college or university 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.