- This is M-F/40 hrs/week role. This is fully onsite role at Elkton,VA until the end of Dec 2024.
- Candidate will be required to go through beta lactam screenings post offer.
- Do not submit anyone who is allergic to beta lactam group of antibiotics.
- DO NOT SUBMIT PHD/MD's/ or any advance degrees as they will be overqualified
- Providing Quality support for vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations and Operations.
- Performing review and approval for investigations, corrective and preventative actions, regulatory commitments, change requests, risk assessments, validation protocols, master batch records and standard operating procedures.
- Provide Quality guidance and assistance in deviation identification and initiation.
- Perform review of batch records and documentation
- Actively participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information, and presenting to inspectors on required topics as Quality representative.
- Supports the preparation of regulatory filings.
- Write, review, approve standard operating procedures and other instructional documents for shop floor.
- Provides training to incoming personnel and ensures compliance with departmental procedures.
- Bachelor's degree in a science discipline (biology, chemistry, engineering, other) or related scientific field and a minimum of two (2) year's experience in Pharmaceutical, Manufacturing, Maintenance or Military environments or GMP.
- OR Master's degree with minimum of 1 year experience in Pharmaceutical, Manufacturing, Maintenance or Military environments or GMP.
- Strong verbal and written communication skills, team skills, personal character, and ethics
- Strong problem-solving skills and a hands-on approach to problem solving, with a bias towards going to see problems for oneself in the field.
- Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.
- Enthusiasm, confidence, and initiative-taking ability needed for continuous learning and its applications.
- Strong desire to succeed and to help others to do the same.
- Demonstrated verbal/written communication and decision-making skills.
- Deviation management experience
- Experience in vaccines manufacturing
- MS office suite (word,outlook,excel,powerpoint)
- SAP
- Electronic batch record system(MES)
- Client V system
-
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Quality Specialist - Elkton, United States - Pyramid Consulting, Inc
Description
Immediate need for a talented Quality Specialist - I (Assistant). This is a 06+ Months contract opportunity with long-term potential and is located in Elkton, VA (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:
Pay Range: $35 - $40/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Note:
Key Responsibilities:
Key Requirements and Technology Experience:
Our client is a leading Healthcare organization and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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