Description:
JOB SUMMARY:
The Senior Quality Control Scientist (SQCS) is the primary technical support contact for peers within the Pharmgate Quality Control Laboratories. The SQCS is also responsible for performing their own primary analytical duties, maintaining quality control and assurance of materials and instrumentation used in the laboratory. Additionally, the SQCS will help assure that daily, weekly, and/or monthly workflow tasks are completed to meet company and department goals. The position is key to supporting Laboratory management while independently applying advanced scientific knowledge to projects and assures adherence to Standard Operating Procedures(SOPs), Current Good Manufacturing Practices (cGMP) and other industry and company required standards and policies.
TECHNICAL WORKFLOW RESPONSIBILITIES:
1. Provide guidance on daily tasks for efficient workflow and assignments in the laboratory.
2. Oversee consistency in training across all areas of the laboratory.
3. Provide opportunities for on-the-job training and SOP review as necessary.
4. Troubleshoot and resolve work problems or assist workers in solving work problems.
5. Communicate difficulties, either production or personnel, with plans for resolution, to management for consultation and resolution approval.
INDIVIDUAL WORKFLOW DUTIES/RESPONSIBILIITIES:
1. Identify and recommend improvements to processes to maintain quality, cost- effectiveness, safety compliance, and other parameters.
2. Perform timely release testing on all incoming raw materials needed for manufacturing and finished goods.
3. Coordinate scheduling of all materials in order to meet company requirements.
4. Ensure that assigned products meet quality requirements for the customer and the company.
5. Draft written reports detailing results of testing analysis.
6. Approve release of raw materials and finished goods.
7. Proactively identify trends in laboratory analysis or functions and act to make improvements and/or communicate to management.
8. Perform operations for CMO support as necessary.
9. Operate and maintain laboratory equipment; identify problems when equipment fails and conduct or recommend repairs.
10. Perform maintenance and calibration of all equipment as needed.
11. Perform peer review of analytical results of peers.
12. Perform peer review of test methods and protocols.
13. Review and/or draft SOPs as needed to update to current procedures.
14. Author and execute written protocols and IQOQs as needed.
15. Cross train to be able to perform sample lab duties adequately and accurately.
16. Act as Quality Department Representative when necessary.
17. Perform other duties as assigned.
Requirements:
REQUIRED SKILLS/ABILITIES:
1. Excellent organizational skills and attention to detail.
2. Thorough understanding of chemical tests and processes.
3. Understanding and proficiency in basic laboratory techniques and scientific instrumentation, including direct HPLC experience and troubleshooting.
4. Ability to follow Standard Operating Procedures (SOPs) and GMP guidelines. Ensure compliance with all NADAs/ANADAs.
5. Excellent time management skills with a proven ability to meet deadlines.
6. Strong verbal and written communication skills and the ability to work with all levels of personnel.
7. Strong analytical and problem-solving skills including the ability to read and understand instructions and materials in English; add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
8. Ability to function well in a high-paced and at times stressful environment.
9. Thorough understanding of FDA and cGMP compliance regulations.
10. Proficient with Microsoft Office Suite, virtual meeting applications, SAP Business One, and other related software.
EDUCATION AND EXPERIENCE:
1. Bachelor of Science in Chemistry, Microbiology or Biology, required.
2. 3-5 years of experience in an FDA regulated pharmaceutical laboratory facility or other highly regulated industry, preferred.
PHYSICAL REQUIREMENTS:
1. Prolonged periods of standing and walking.
2. Exposure to various chemicals and compounds.
3. Prolonged periods of sitting at a desk working on computers.
4. Ability to occasionally lift 50 lbs. from floor to waist level.
5. Ability to occasionally climb stairs.
