QC Analyst II

Job Description

Job Title: QC Analyst II

Location: Watertown Massachusetts 02472

Duration: CONTRACT - 9-12 months

Shift: 1st Shift – 9am-5pm Monday- Friday (PLEASE NOTE – Must have flexibility to work on weekends up to 2X a month.

Job Description:

This person will report directly to the quality control manager and will be responsible for all aspects of quality control in respect to clinical trial materials and commercial products as required. This position provides production support for analytical quality control testing of pharmaceutical raw materials and drug products.

The individual will work in the QC laboratory located in Watertown, MA with potential to relocate to the Northbridge, MA QC laboratory when appropriate. The individual will ensure that all products are tested,in accordance with all applicable GxP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines), as well as internal company procedures.

Individual responsibilities

Perform QC analytical testing for drug products and raw materials (release and stability samples). Evaluates and reduces QC analytical testing data in a timely manner.

Perform technical review of QC testing data and external testing data.

Perform routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory’s operational areas.

Provide support for inspection and testing of incoming raw materials.

Provide support to analytical development for QC analytical method validation and method transfer.

Assist in authoring and reviewing standard operating procedures, test methods, and work instructions related to QC activities.

Assist in QC sample management for internal and external testing samples.

Prepare reagents and standards per procedure ensuring proper handling, storage and disposal of hazardous materials.

Provide support for analytical data tracking and trending.

Work under minimal supervision to ensure all work is performed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.

Identify laboratory anomalies and/or discrepancies then escalate to management in a timely manner. Work with laboratory personnel and management to address issues.

Provide support for investigations regarding deviations, out-of-trend (OOT)/out-of-specification (OOS) results

Provide analytical testing support for development protocols and reports as appropriate

Assist in development of training programs for QC analysts.

Perform workload to meet schedules, timelines, deadlines as per procedure’s and/or department requirements.

Support internal and external audits and regulatory inspections, as required.

Participate as Subject Matter Expert (SME) during Regulatory Inspections, as appropriate.

Primary skills and knowledge required include, but are not limited to the following:

Experience in analysis of pharmaceutical products by USP/EP methods required.

Knowledge of cGMPs and related compliance regulations and guidance’s is required (e.g. Title 21 CFR Parts 11, 210/211, 820,) USP/EP / ICH Guidelines.

Hands on experience with analytical chemistry instruments and techniques: High-Performance Liquid Chromatography (HPLC) required. (Empower Software experience is a plus). Experience with basic laboratory equipment such as balances, automatic pipettes, pH meters

Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently

Must be a team player with integrity and concern for the quality of Company products, services and staff members.

A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and suppliers.

Must have excellent organizational, verbal communication, technical documentation and computer skills.

Routinely exercises sound judgment, reasoning and problem solving

Capable of completing assigned responsibilities under minimal supervision and keeping management informed of work status.

Flexible and able to respond quickly to shifting priorities to meet deadlines.

Position may involve use of reagents and other chemical compounds that are considered hazardous.

Ability to communicate and work independently with scientific/technical personnel in both internal and external setting.Company Description

Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.