Specialist Quality Control

ZipRecruiter; Thousand Oaks (CA); Remote; USD 100,000 - 125,000; Full time

Job summary

A leading company is seeking a quality control specialist to oversee routine procedures and process improvement projects. This remote contract position offers a dynamic role focused on compliance, communication, and quality assurance within a pharmaceutical environment. Candidates should possess a relevant degree and significant experience in related fields. The role includes managing documentation, conducting investigations, and ensuring adherence to safety and regulatory standards, contributing actively towards corporate quality initiatives.

Benefits

Comprehensive benefits package

401K plan

Medical, dental, and vision insurance

AD&D and life insurance

Qualifications

• Doctorate in Science or Chemistry, or Master's with 3 years experience, or Bachelor's with 5 years experience.
• Excellent communication, technical writing, and project management skills.
• Strong knowledge of GMPs/CFRs and experience in quality assurance.

Responsibilities

• Perform routine procedures and process improvement projects supporting Corporate Quality Control.
• Develop, revise, and audit controlled documents with multi-site impacts.
• Ensure compliance with safety guidelines and GMP requirements.

Skills

Quality control

Quality Assurance

Good Manufacturing Practice

CMC

Education

Bachelors degree in Science or Chemistry

Tools

SAP Quality Management (QM) Module

Job description

Job DescriptionJob Descriptionjob summary:

• Under general supervision, this position will perform routine procedures (i.e., NC/CAPA/CC) and process improvements projects to support Corporate Quality Control. Specific responsibilities include performing investigations to support corrective actions, procedures revision, Training portfolio, monitoring and revising SAP Mater data Quality Inspection plans, and projects implementation plan. Will also be responsible for documenting, computing, compiling, interpreting, reviewing and entering data. Additional responsibilities include providing and communicating results, maintaining global process trackers, develop project plan, support Business Continuity and Risk Management objectives, and initiating and/or implementing changes in controlled documents. Must learn and comply with safety guidelines, and cGMPs/CFRs which includes, but is not limited to, the maintenance of Corp QC training portfolio, training records, multisite procedures, CAPA/Change control records, written procedures and general support to Corporate QC improvements projects.

location: Telecommute
job type: Contract
salary: $35.00 - 44.91 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Provide summary reports, data analysis and ensure flow of communication between RM Networks including following up and resolving issues that arise.
• Provide expert support to RM IQA network.
• Coordinates, manages, and performs changes to the multisite documents or in response to change requests approved by management.
• Work within the Information Services and Quality Systems teams to foster good communication throughout the project life cycle.
• Ensure compliance - which includes implementing procedures that enhance GMP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Support of investigations and corrective actions.
• May serve as subject matter expert to develop technical training.
• May perform routine work in a specific area of responsibility as necessary.
• Represents the department/organization on various team.
• Independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• May resolve issues with outside resources.
• Performs special projects as requested by supervisor.
• Available to work overtime or weekends to conduct any special assignment as per business request.
• *Other functions that may be assigned

qualifications:

EDUCATION/LICENSES

• Doctorate degree in Science or Chemistry OR Masters degree in Science or Chemistry & 3 years of directly related experience OR Bachelors degree in Science or Chemistry & 5 years of directly related experience

COMPETENCIES/SKILLS

• Understand, support and demonstrate the Company values.
• Excellent communication skills, facilitation and presentation skills.
• Excellent technical writing skills.
• Strong computer operation skills including Word processing, presentation, database and spreadsheet application skills.
• Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.
• Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.
• Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.
• Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.
• Knowledge of pharmaceutical processes.
• Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.
• Extensive knowledge and application of GMPs/CFRs.
• Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines.
• Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.
• Extensive knowledge and application of SAP Quality Management (QM) Module
• Advanced skills in solving complex problems.
• Advanced data trending and evaluation.
• Strong skill in working independently and to effectively interact with various level.
• Ability to interact with regulatory agencies both orally and in writing.
• Initiate, coordinate and lead cross functional team.
• Excellent skill in leading, motivating, influencing, and negotiating.

QUALIFICATIONS

• Major in Science and / or Chemistry with approved Computer Sciences courses

#LI-CV1

skills: CMC, Quality control, SOP, Quality Assurance, GMP (Good Manufacturing Practice)

Equal Opportunity Employer: , , , , , , , , Genetic Information, , Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [e-mail].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term , and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.