Description: Job Title - Quality Control Chemist
Location - Frederick, MD
Onsite Swing Shift - (Wed-Sat 1:00 pm -23:30 pm shift)

Responsibilities (include but are not limited to):

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
• Work with internal and external resources to maintain lab in an optimal state.
• Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.
• Maintains laboratory instruments for calibration and routine maintenance
• Author or revise SOPs, qualification/validation protocols and reports.
• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
• Provide updates at daily and weekly meetings.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.

Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.

• Gather metric information for use in continuous improvement of areas of responsibility.
• Perform other duties as required.

Basic Qualifications:

• Bachelor’s Degree OR
• AA Degree and 2 years’ experience in biotechnology or related field and Quality Control experience OR
• High School Degree and 3 years’ experience in biotechnology or related field and Quality Control experience

Preferred Qualifications:

• Strong knowledge of GMP, SOPs and quality control processes.
• Identifying, writing, evaluating, and closing OOS’s and investigations.
• Proficient in MS Word, Excel, Power Point and other applications.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
• Preferred: Experience in the biotech and/or pharmaceutical industry.

Job Type: Contract

Pay: $33.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• Monday to Friday

Application Question(s):

• Are you comfortable with Rate $33/hr on W2?
• Do you have experience with analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays? If yes with a which client and is it mentioned in resume? If not please mention in your resume before applying (MUST MENTIONED)?
• Do you have experience with quality systems and regulatory requirements (21 CRF Part 11/210/211).? If yes with which client? and is it mentioned in resume? If not please mention in your resume before applying (MUST MENTIONED)
• Are you comfortable with Onsite Swing Shift - (Wed-Sat 1:00 pm -23:30 pm shift)??
• Are you comfortable onsite in Frederick MD?

Experience:

• Molecular biology: 3 years (Required)
• SOP: 3 years (Required)
• Laboratory management: 3 years (Required)

Work Location: On the road