What are the responsibilities and job description for the QC Research Associate (cGMP/ ELISA/ PCR) - Frederick, MD position at Rangam?
Job Title - Quality Control Chemist
Location - Frederick, MD
Onsite - Shift flexibility preferred
shift is Wed-Sat 07:00am-05:30pm
IMPORTANT:
- For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (07:30 am-16:00pm) to complete New Hire Orientation and Manufacturing On-boarding Technical Training.
- After the 7 weeks, the contractor is deployed onto their agreed upon 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: $29.00 - $30.00 per hour
Expected hours: 40 per week
Benefits:
- Dental insurance
- Health insurance
Schedule:
- 8 hour shift
Education:
- Bachelor's (Required)
Experience:
- Quality and research: 3 years (Required)
- Flow Cytometry, ELISA and qPCR: 2 years (Required)
Ability to Commute:
- Frederick, MD 21704 (Preferred)
Ability to Relocate:
- Frederick, MD 21704: Relocate before starting work (Preferred)
Work Location: In person
Salary : $29 - $30
