USA - Quality Control Analyst

USA - Quality Control Analyst#26-10304

$54.54-$58.06 per hour

Newbury Park (Thousand Oaks), CA

All On-site

Job Description

Title: QC Analyst II

As a QC Analyst II, you will support various activities within the QC department. Key responsibilities are to execute analytical method transfers, including raw materials, for use in a cGMP environment in Quality control. You will be responsible for conducting biological or chemical and physical analyses on raw materials, in-process samples, drug substance and final product samples and other samples collected from manufacturing areas.

Essential Duties and Responsibilities:

Conduct biological, chemical, and physical analyses on samples including raw materials, initial, in-process and final products, and samples collected from environmental monitoring according to SOP and pre-approved protocols.

Drive implementation of new methodologies, or new sample types into existing methods in a QC laboratory

Support Investigation of nonconformances and troubleshoot unexpected results.

Handle multiple tasks concurrently including testing and inventory management in a timely and appropriate manner.

Perform review of test data, which includes overall documentation practices (CGDP). May perform release functions in LIMS or other computerized systems.

Support generation and documentation of validation protocol deliverables.

Draft and update, as required, QC SOPs.

Perform test equipment, equipment maintenance and calibrations as required.

May perform other duties as assigned.

Qualifications

General understanding & knowledge of the following areas:

o Laboratory functions, test methods, equipment (including but not limited to analytical equipment (e.g. HPLCs, plate readers, processes and applicable procedures.

o Laboratory safety including standard precautions and hazardous and biohazardous chemical handling.

o Wet and instrumental methods of analyses.

o Operating and troubleshooting procedures for lab equipment

General knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices is preferred.

Knowledge of quality and regulatory requirements pertinent to pharmaceutical manufacturing labs is a plus.

Ability to write detailed investigation reports, knowledge of how to implement investigation strategies and apply root cause failure analysis is a plus.

Solid team player, able to meet deadlines and changing priorities.

Able to communicate effectively with managers, peers and subordinates.

Very detailed oriented and able to produce high quality of work.

Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Ability to prioritize multiple projects/workflows and manage time efficiently to meet established timelines.

Strong decision-making skills, technical problem-solving ability, and analytical skills.

Education and/or experience

High School degree or equivalent required; Bachelor's Degree in Chemistry, Microbiology or Biological Sciences strongly preferred

Minimum 2 years of related work experience

Experience in quality operations, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.

Physical Demand

The overall physical exertion of this position requires light to medium work.

May be required to sit between 3-4 hours, walk between 1-2 hours and stand for over 4 hours

May be required to bend at the neck/waist, squat and climb (using step stools and ladders) between 1-2 hours

May be required to reach above/below the shoulder, kneel, twist at the neck/waist between 1-2 hours

May be required to lift up to 50lbs between 5-10lbs up to 30x per shift, 11-25lbs up to 5x per shift, and 26-50lbs up to 5x per shift

May be required to carry 5-10lbs up to 30x per shift up to 20ft, 11-25lbs up to 5x per shift up to 5ft, and 26-50lbs up to 5x per shift up to 5ft

Requires repetitive use of both right and left hands over 4 hours

May require simple and power grasping between 3-4 hours

May require fine manipulation up to 1 hour

May require pushing/pulling with hands/arms between 3-4 hours

May require office work activities with hands/arms between 3-4 hours in all Quality areas

May be required to gown frequently and balance when gowning into clean areas

May be exposed to noise above 85 dBA. This may require hearing protection and other protective equipment to be worn.

May work and have exposure to hot, cold, wet environment/conditions.

May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes (may require respiratory protection)

May be required to work at heights above floor level

Will not be required to operate foot controls or repetitive foot movement

May require the use of special visual or auditory protective equipment

May be required to work with biohazards such as: bloodborne pathogens, sewage, or medical waste in all Quality areas.

May be required to work in confined areas.

Working Environment

Laboratory environment; inside working conditions

Must wear personal protective equipment due to safety requirements in designated lab areas. May be required to work in controlled or clean room environments requiring special gowning.

May be required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.

May work around Methotrexate, which is a known cell growth inhibitor.

May require immunization before performing work within the manufacturing area.

Overtime may be required at times.

May be required to work or be assigned to a different shift as needed.

May be required to work weekends and holidays.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.