Senior Quality Control Associate

Job description

Summary of Major Responsibilities:
The Senior Quality Control Associate 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 will provide technical expertise in developing and documenting new procedures and revising existing procedures for quality control.

Essential Duties and Responsibilities:
Conduct analytical and functional testing of raw materials, intermediates, and finished goods in support of R&D, process and productcharacterization, the validation program, stability, quality control, and troubleshooting efforts using molecular biology methods as per CAP/CLIA regulations.

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 reviewing of quality documents, such as standard operating procedures (SOPs) and raw material specifications that are compliant with cGMP/GLP guidelines.

Take inventory and stock 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.

Apply strong analytical and problem-solving skills.

Ability to make decisions with limited information and operate with autonomy.

Apply strong documentation skills and attention-to-detail necessary in a GMP environment.

Ability to work effectively in team situations, as well as independently.

Apply 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.

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.

Maintain regular and reliable attendance.

Ability to act with an inclusion mindset and model these behaviors for the organization.

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 comply with any applicable personal protective equipment requirements.

Ability to work with hazardous or flammable materials such as chemicals, radioactivity, electrical equipment, etc. so as not to endanger oneself or others.

Qualifications:
Minimum Qualifications

Bachelor's Degree in Molecular Biology, Biological Science, or field as outlined in the essential duties; or Associates Degree in Molecular Biology, Biological Science, or field as outlined in the essential duties and 2 years of relevant experience as outlined in the essential duties.

5+ years of experience in molecular quality control testing.

ASCP Certification such as MLT, MLS, MB, SMB or ability to obtain within 1 year.

Manual pipetting and testing experience.

Proficient in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.

Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Authorization to work in the United States without sponsorship.

Preferred Qualifications

3+ years of experience in a biotech environment, preferably in a CAP/CLIA regulated lab and/or ISO13485.

Working knowledge or coursework with databases, spreadsheets, and statistical programs.

Professional working knowledge or coursework in complex molecular biology or analytical chemistry techniques.

Basic working knowledge with SAP.

EEO Disclosure:
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.