Quality Control Associate II

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Job description

Summary of Major Responsibilities

The Quality Control Associate II will participate in and may take leadership for a variety of quality control functions, including, but not limited to, raw material, in-process material, finished goods, stability testing, process and method development, characterization and validation, and quality documentation generation. This position may provide technical expertise in developing and documenting new procedures and revising existing procedures for quality control.

Essential Duties and Responsibilities

* Conduct functional testing of raw materials, intermediates and finished goods in support of R&D, process and product characterization, the Validation Program, Stability, Quality Control and troubleshooting efforts using molecular biology methods.
* Develop, qualify, troubleshoot and routinely perform analytical and functional techniques associated with oligonucleotides, enzymes, antibodies, standard molecular biology reagents, and complex molecular diagnostics.
* Participate in Out of Specification and NCMR, Deviation report generation and CAPA efforts.
* Review and execute protocols supporting Process, Test Method Validation and Stability Studies in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.
* Participate in drafting and review of quality documents, including but not limited to, Standard Operating Procedures and raw material specifications that are compliant with cGMP/GLP guidelines.
* Inventory and stocking of reagents.
* Work according to CLIA/CAP standards and regulations.
* Provide support in cross functional teams, as required.
* Support the Operations department in other non-laboratory functions, as determined by Operations management.
* Evidence of strong analytical and problem-solving skills, and ability to make decisions with limited information and operate with autonomy.
* Strong documentation skills and attention-to-detail necessary in a GMP environment.
* Proven ability to work effectively in team situations as well as independently.
* Excellent oral and written communication and interpersonal skills.
* Ability to follow procedures or experimental plans.
* Ability to interpret technical data.
* Ability to work in a fast paced ever changing environment.
* Support and comply with the company's environmental health and safety procedures.
* Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
* Support and comply with the company's Quality Management System policies and procedures.
* Regular and reliable attendance.
* This role works with PHI on a regular basis both in paper and electronic form and have access to various technologies to access PHI (paper and electronic) in order to perform the job.
* Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
* Ability to work designated schedule.
* Ability to work nights and/or weekends.
* Ability to lift up to 50 pounds for approximately 5% of a typical working day.
* Ability to utilize lab equipment for 80% of a typical working day.
* Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
* Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
* Ability to work on a computer and phone simultaneously.
* Ability to use a telephone through a headset.
* Ability to comply with any applicable personal protective equipment requirements.
* Ability to work with hazardous or flammable materials (e.g. chemicals, radioactivity, electrical equipment) so as not to endanger oneself or others.

Qualifications

Minimum Qualifications

* Bachelor's degree in Molecular Biology or a science related field with 2+ years of relevant experience; or an Associate's degree and 3 years of relevant experience in Molecular Biology or a science related field in lieu of degree.
* 1+ years of experience using laboratory equipment supporting Molecular Biology workflows in a CAP/CLIA regulated lab.
* Proficient in Microsoft Office.
* Manual pipetting and testing experience.
* ASCP Certification (MLT, MLS, MB, SMB) or ability to obtain within 1 year of employment.
* Authorization to work in the United States without sponsorship.
* Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

* Proficient documentation skills in accordance with GMP requirements.
* Working knowledge or coursework with databases, spreadsheets, and statistical programs.
* 1+ year of experience in a biotech, preferably in a CAP/CLIA regulated lab and/or ISO13485, environment.
* Professional working knowledge or coursework in complex molecular biology.
* Basic working knowledge with SAP.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.

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