Quality Control Analyst Job at Alpha Business Solutions, Lexington, MA

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  • Alpha Business Solutions
  • Lexington, MA

Job Description

Position Title: QC Analyst 1

Location: Lexington Ma, USA

Duration: 6+ Months

Primary duties of this position will focus on the daily lab operations and execution

of testing to support manufacturing operations. Testing may include but not limited to

samples from drug substance and drug product, manufacturing, stability, raw materials

and various protocol studies using test methods. The assays range from pH, enzyme

concentration to more complex assays such as SDS silver Gels, PCR, DNA and enzyme

activity. This position is expected to maintain operational and GMP readiness of the QC

areas. In addition, this position will participate in more complex projects, Operational

excellence initiatives and various quality systems.

Discretion: Work is closely supervised. Follow specific, detailed instructions

Impact: Contributions are usually limited to task-related activities. Errors do not typically have

major effect on the organization

Specific QC Focus Area:

Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO,

Appearance, Subvisible particles), Enzyme Actitity assays, DNA, PCR, Free Thiol

Responsibilities: Job Function and Description

% of Time Job Function and description

80% Testing execution

10% QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab housekeeping, support for other QC groups if needed.

10% Compliance and quality systems (SOP revisions, input to quality system

Education and Experience Requirements

Essential: Bachelor's degree and minimum of 0-2 years related experience

Desired: GMP knowledge, work experience

Key Skills, Abilities, and Competencies

Limited use and/or application of basic principles, theories and

concepts. Limited knowledge of industry practices and standards. Position requires

critical thinking.

Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science

understanding

Complexity and Problem Solving:

Solve routine problems of limited scope and complexity following established

policies and procedures. Works on problems of limited scope. Follows standard

practices and procedures in analyzing situations of data from which answers can be

readily obtained. Builds stable working relationships internally.

Contacts are primarily with immediate supervisors, and other personnel in the

section or group

Other Job Requirements

100% On-site

Limited to no travel expected.

The following physical abilities are required to fulfil the job duties:

· Repetitive bending and reaching to setup and break down equipment

· Ability to work around chemicals

· Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases · Ability to walk and stand for periods of time

Job Tags

Work experience placement, Immediate start,

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