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Quality Control Chemist

3 months ago

Frederick, United States Validation Associates Full time

**Description**:
**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.
- 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: Up to $38.00 per hour

Schedule:

- 8 hour shift

**Experience**:

- Flow cytometry: 1 year (required)
- PCR: 1 year (required)

Work Location: On the road