QC Specialist

---

Job description

Day to Day Responsibilities:
Quality Control Specialist
Key Responsibilities
• Comply with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
• Perform analytical laboratory testing of raw materials, intermediates, finished good products, and stability studies - ensuring products meet requirements.
• Inspect and approve incoming raw materials.
• Review and approve manufacturing batch records.
• Maintain records of all analysis information (hard copies or electronic).
• Write, review, and revise SOPs and other documents as necessary.
• Initiate NCMRs, change controls, and deviations.
• Participate in root cause investigations for NCMRs, NCRs, and vendor related issues.
• Continuous improvement to processes and methods.
• File and sort documents as needed.
• Maintain a cleanliness, organization, and stock the lab with supplies as needed.
• Assist QA with inspection or release of products as necessary.
• Assist department management in the execution/implementation of projects as requested.
Skills / Qualifications

Requirements:
• Bachelor's degree chemistry, biology, or related field with 3-5 years of laboratory experience.
• QC lab testing experience: sterility testing, endotoxin, chemical properties testing, nuclease detection assays, FTIR, USP water testing, spectroscopy and electrophoresis.
• Knowledge and control of analytical equipment including calibration and maintenance.
• Knowledge of cGMP, cGDP, cGLPs, ISO13485, 21 CFR regulations.
• Knowledge of USP and ACS guidelines and criteria.
• Strong writing verbal skills to effectively read and write SOPs, reports, and communicate.
• Proficient in software such as Word, Excel, and Outlook.
• Strong problem solving, multitasking, and prioritization skills.
• Ability lift and carry at least 30lb and stand for extended periods of time.

Preferred:
• Knowledge or experience of monitoring of cleanrooms and production areas.
• Experience with aseptic technique to perform critical testing.
• Basic background in microbiology.
• Statistical knowledge and techniques.
• Experience using laboratory and inventory management systems (Process Pro)

** For Immediate Consideration, email Katie at

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . - provided by Dice