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Quality Control Openings in Rockville, MD

Job Description

Summary of Position level II

This position is responsible for performing activities to support analytical testing programs to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.

For level III

Performing activities to support analytical testing programs to ensure compliance with cGMP standards including in-process, product release and stability testing. This individual will guide and partner with lower level QC analysts to provide feedback and technical information. This individual will also ensure accurate documentation, timely completion of all analytical related testing, and timely review of data, while adhering to standard operating procedures and cGMPs.

Responsibilities and Job Duties:

level II

• Performs routine analytical testing including more complex methods such as HPLC, CE, ELISA, and Cell Culture as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).

• Performs peer review of test data generated by other analysts as needed to ensure data integrity and adherence to standard operating procedures and GMPs.

• Reports out of specification results from testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.

• Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.

• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.

• Identifies opportunities for process improvement and makes recommendations to team leader.

• Revises and updates standard operating procedures, as needed.

• May participate in special projects related to problems encountered with testing and instruments, and make recommendations for solutions that will minimize future issues.

Level III

• Performs routine analytical testing including complex methods such as HPLC, CE, ELISA, and Cell Culture as well as basic methods such as concentration by UV absorbance, pH, conductivity, and osmolality, for in-process, product release, and stability samples on a daily basis in accordance with all protocols and procedures. Enters data into Laboratory Information Management System (LIMS).

• Performs peer review of test data generated by other analysts to identify discrepancies and out of range results and to ensure adherence to standard operating procedures and GMPs. Identifies analytical data trends and reports findings and provides recommendation to supervisors for review and consideration.

• Conducts investigation when there are out of specification results from testing and reports to supervisor.

• Initiates and monitors progress of analytical related Quality event records (e.g., Deviations and CAPAs) and conducts investigations to determine root cause and possible resolution.

• Develops, revises, and updates standard operating procedures, as needed.

• Collaborates with QC team members to participate in the development, transfer, and validation of analytical testing methods and conducts training on analytical test methods to other QC Analysts as needed.

• Overseas lab equipment calibration and maintenance processes as required for testing per standard operating procedures, and raises any concerns about equipment to supervisor for resolution.

• Participates in troubleshooting of analytical test methods and instruments, as needed.

• Performs special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues.

• Mentors and trains lower lever analysts, as needed.

• Prepares general lab solutions and buffers as needed and monitors expirations of these solutions and buffers.

Skills

Quality control, Gmp, Chemistry, capillary electrophoresis, liquid chromatography, Isoelectric Focusing, Hplc, ELISA, Cell Culture, product release, stability testing, LIMS, gel electrophoresis, UV absorbance

Top Skills Details

Quality control,Gmp,Chemistry,capillary electrophoresis,liquid chromatography,Isoelectric Focusing,Hplc,ELISA,Cell Culture,product release,stability testing,LIMS

Additional Skills & Qualifications

Qualifications level II

Education & Experience

• High School Diploma and minimum of four years of experience in performing analytical/chemistry testing.

• Associate’s degree in a scientific area of study with three years of related experience

• Bachelor’s Degree in a scientific discipline and minimum of two year of direct related experience

• Experience in one or more of the following areas required: HPLC, CE, ELISA, Cell Culture, Gels, UV absorbance, pH, conductivity, osmolality, Quality Control, and GMP testing.

Knowledge, Skills and Abilities

• Strong knowledge of good laboratory practices.

• Ability to work independently on assigned methods and follow procedures.

• Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.

• Ability to resolve problems independently and responsively but also know when to raise issues with management.

• Be able to work in a team environment in a cooperative and respectful manner.

• Ability to stand for periods of time when performing tasks on the floor.

• Ability to work a varied schedule including off shift and weekends.

• Ability to lift up to 50 pounds.

Level III

Education, Experience, & Credentials

• High School Diploma and minimum of 8 years directly related experience

• Associate’s degree in scientific field of study and 5 years of experience

• Bachelor’s Degree in a scientific discipline and minimum of 4 years experience

• Experience in one or more of the following areas required: Potency testing, Chromatography testing, Quality Control, Raw Material testing, and/or GMP testing.

Knowledge, Skills and Abilities

• Working knowledge of good laboratory practices.

• Excellent understanding of GMPs related to the biotech or pharmaceutical industry

• Ability to organize and prioritize daily activities to meet internal customer needs in a fast-paced environment.

• Ability to work on extremely complex problems in which analysis of situation or data requires an in-depth

Experience Level

Intermediate Level

Job Type & Location

This is a Contract position based out of Rockville, MD.

Pay and Benefits

The pay range for this position is $34.00 - $44.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Rockville,MD.

Application Deadline

This position is anticipated to close on Jan 24, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.