Jobs
>
Atlanta

    QA Manager - Atlanta, United States - PHARMALOGIC HOLDINGS

    Default job background
    Description

    Job Description

    Job Description

    PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside.

    PharmaLogic offers you an exceptional opportunity to join our dynamic team as a Quality Assurance Manager

    If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.

    Position Title:QA Manager

    Role Summary:

    As the site Quality Assurance Manager, you will play a vital role in the PharmaLogic quality program to assure compliance with cGMP and other standards for the manufacture of drugs for administration to patients. Responsible for completion of required quality assurance tasks of finished drug product as directed by cGMP SOPs and serves as site expert on PET quality assurance. The position involves a hands-on role in all quality assurance duties for the site, including materials acceptance and quarantine, batch release & record review, drug quality control, sterility, environmental monitoring, equipment maintenance / qualification/ calibration, investigation (IR, OOS, deviation, etc.) and corrective actions (CAPA), SOP writing, maintenance and review, inspection readiness, data quality and integrity, ANDA documentation and other routine QA functions. The site QA is responsible for training documentation for the staff on QA related activities.


    The site QA is the responsible person for FDA inspections at the site and is listed on the FDA filing and associated permits as applicable. Ideally, there will be separation of QA functions from production and QC functions. However, depending on the size of the facility, these activities may be performed by the same person if there is the ability to segregate batch release from production through appropriate cross-training for batch release. For smaller facilities, the site QA may assume other duties which may include production activities, operation of the facility's cyclotron and associated chemistry modules and analytical equipment for production and QC of PET radiopharmaceuticals. The position may be required to perform various radiation safety and quality related tasks as directed by management.


    Job Responsibilities and Duties:

    Ensure compliance with all regulatory commitments and company policies and SOPs including cGMP and radiation safety.

    Actively promote adherence to SOPs, as well as safety rules and awareness. Report and take initiative to correct safety & environmental hazards.

    Provide immediate notification of quality related issues to site Manager, PET Operations Management and Q&R as necessary.

    Oversee production operations to assure that PET drugs meet requirements for identity, strength, quality and purity.

    May Perform PET radiopharmaceutical Quality Control (QC) in cGMP environment

    May perform aseptic processing related tasks

    Responsible for quality assurance oversight of routine production, packaging and shipping of radioisotopes.

    Examine and approve/reject components, closures, in-process materials, packaging materials, labeling and finished dosage forms to assure that all meet specification; manage onsite inventory quarantine and control process according to SOPs to assure specifications are met.

    Assure approved vendors used and maintain documents and records, including COA.

    Review batch, laboratory and production records to assure completeness, accuracy and conformance before batch release; authorize or reject batch according to SOPs or oversee batch release by other qualified team members.

    Perform batch trending analysis.

    Notify facility manager if any recall necessary to assure that recalled materials are not administered to patients.

    Initiate change to SOPs, participate in authoring and review of SOPs, maintain documents under control in QMS. Assure SOPs match processes and procedures in PET manufacturing operation and report concerns to Management.


  • SUCCESS KOREA

    Program Manager

    6 days ago


    SUCCESS KOREA Atlanta, United States

    채용제목 · Program Manager (신규사업 : Land) · 회사소개 · 국내우량 IT기업 · 업무내용/자격요건 · Project&ProgramManager · 제품개발프로세스관리 · 프로젝트예산/실적관리 · 해외고객사대응및유관업체커뮤니케이션 · 제품개발Co-work · 자격요건 · 전자공학및기계공학관련학과전공(대졸이상) · 프로젝트관리경험및PM/PL경험자 · 프로젝트관리tool활용(MSproject,WBS,VCRM) · 팀원,고객등상호간원활한커뮤니케이션능력을갖춘자 ...


  • Home Depot / THD Atlanta, United States

    **Position Purpose**: · The Product Management Manager is responsible for attracting, retaining and developing top talent focused on assessing market needs and inspiring cross-functional product teams to find the fastest way to achieve value around those needs. The Product Manage ...

  • Hobart Service

    District Manager

    3 days ago


    Hobart Service Atlanta, United States

    **Company Description** · Hobart Service, an Illinois Tool Works Company, has been in business for over 125 years and is the trusted source for Commercial Food Equipment Service Solutions. We have over 1,700 associates nationwide who serve as valued partners to our customers. Our ...

  • Tilray

    Logistics Manager

    1 day ago


    Tilray Atlanta, United States

    **Logistics Manager - Atlanta, GA** · **_About Tilray Brands_** · - Looking to develop your career at the forefront of a rapidly expanding industry?_ · **Tilray Brands'** beverage business is one of the fastest growing in United States with nation-wide and international distribut ...

  • Infinity Home Services

    Warehouse Manager

    2 days ago


    Infinity Home Services Fulton, United States

    Are you a driven individual with a passion for warehouse management? Do you thrive in environments that value independence and initiative? If so, we have the perfect opportunity for you · We are currently seeking a Warehouse Manager to oversee operations at our off-site 20,000 sq ...

  • JINYA Ramen Bar

    General Manager

    3 days ago


    JINYA Ramen Bar Atlanta, United States

    **Job Title: General Manager** · **POSITION STATUS: Exempt Salaried** · **SALARY RANGE: Varies on Experience** · **Direct Oversight: FOH/BOH - Overall Operations** · **Reports To: Director of Operations and/or VP of Operations** · **JOB SUMMARY**: · The General Manager serves as ...

  • Howmet Aerospace

    Plant Manager

    1 day ago


    Howmet Aerospace Whitehall, United States

    Howmet Engine Products, a division Howmet Aerospace, seeks motivated and experienced leadership to join our team The **Plant Manager **position is responsible for providing leadership to and managing all business operations and can be based out of one of our US locations: · - Bra ...

  • GRANT PARK COFFEEHOUSE

    Assistant Manager

    3 days ago


    GRANT PARK COFFEEHOUSE Atlanta, United States

    **Benefits** · - We offer many great benefits, including **free early access to your pay** through Homebase. · **Responsibilities**: · *Train, coach, and develop employees and team leaders *Delegate tasks to team and provide follow-up *Hold team accountable for their performance; ...

  • Terminix | Forest Park

    Service Manager

    1 week ago


    Terminix | Forest Park Atlanta, United States

    **What is this role about?** · Our Service Managers play a key leadership role in our local Terminix branches. This role is all about leading and motivating our local Pest Technician Teams to provide outstanding service delivery of Terminix products to our valued customers. · **W ...

  • SKLD Whitehall

    Unit Manager

    1 week ago


    SKLD Whitehall Whitehall, United States

    : · **Position Summary**: · In keeping with our organization's goal of improving the lives of the Residents we serve; The Unit Manager provides, plans, coordinates, or manages nursing care and health education to nursing home residents on assigned unit throughout all hours of ope ...

  • Marriott International, Inc

    Operations Manager

    1 day ago


    Marriott International, Inc Atlanta, United States

    **Additional Information** Evening Shift · **Job Number** · **Job Category** Rooms & Guest Services Operations · **Location** AC Hotel Atlanta Airport Gateway, 2079 Hospitality Way, Atlanta, Georgia, United States VIEW ON MAP · **Schedule** Full-Time · **Located Remotely?** N · ...


  • MultiFamily / Communities Atlanta, United States

    DHI Communities is a multifamily development division of D.R. Horton, Inc. · **Essential Duties and Responsibilities** include the following. Other duties may be assigned.- Prepare preliminary and final construction schedules- · - Manage and coordinate consultants and obtain a co ...


  • Innovative Roofing Group Atlanta, United States

    **Base pay: $85k-$100k + bonus, benefits and car allowance. · **Position**:Estimator & Project Manager** · **At Innovative Roofing Group the Estimator & Project Manager is responsible for estimating, proposing, bidding, selling and managing roofing projects in line with profit ex ...


  • AMERICAN CANCER SOCIETY Atlanta, United States

    The people who work at the American Cancer Society focus their diverse talents on our lifesaving mission. It is a calling. And the people who answer it are fulfilled. · **This is a remote role that can be home based anywhere in the United States.** · **MAJOR RESPONSIBILITIES** · ...


  • JINYA Ramen Bar Atlanta, United States

    **JOB TITLE: Restaurant Front of House Manager** · **POSITION STATUS: Exempt Salaried** · **SALARY RANGE: Varies on Experience** · **DIRECT OVERSIGHT: FOH/Overall Restaurant Operations** · **REPORTS TO: General Manager** · **JOB SUMMARY**: · Our FOH Manager serves at the ambassad ...


  • Wellstar Health System, Inc. Atlanta, United States

    **Facility: VIRTUAL-GA** · **Job Summary**: This is an operational manager role, developing analytics and visualizations as well as managing and supporting team members in the development of analytics and visualizations. The primary responsibility of the Manager of Business Intel ...


  • CleanNet of Atlanta Atlanta, United States

    CleanNet USA is a national leader in the Franchised Commercial Cleaning industry. The Atlanta office is seeking quality control professional to manage metro Atlanta territory. · Overview · - Manage janitorial clients in specific geographic territory in the greater Atlanta area · ...


  • Cumulus Media Atlanta, United States

    **The audio industry is on fire - **from podcasting and streaming to smart speakers and live radio - and it's never been a more exciting time to join and grow with one of the country's largest and most sophisticated audio companies** · **Cumulus Media** | **Atlanta** currently fe ...


  • Atlanta Audio & Automation Atlanta, United States

    **Benefits**: · - 401(k) · - 401(k) matching · - Dental insurance · - Health insurance · - Paid time off · - Vision insurance · Atlanta Audio & Automation is a small fast paced business working in the exciting world of smart home electronics and home automation. We are looking fo ...


  • The Integral Group LLC Atlanta, United States

    **Specific Duties and Responsibilities**: · **A. Accounts Receivable** · 1. Accept and accurately post rent and other payments in Yardi. · 2. Ensure residents are correctly set up to use online, electronic and WIPS payment · 3. Address late rent payments by closely following IPM ...