Quality Control Spec I Jobs

BS in chemistry, biology or related discipline or equivalent combination of education and experience

0-2 years of experience in a laboratory environment

Conduct environmental monitoring in the clean space

Review data for compliance with specifications and GMP regulations

Plan and schedule work assigned to them

Writes/revises QC documents within their scope of expertise

Bachelors in a scientific discipline, Associates in a scientific discipline (with additional experience) or equivalent level of knowledge, skills and abilities

Bachelors with 1 year of related experience or Associates with 2 years of related experience, or equivalent

Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.)

Good organization and documentation skills

Leading pay and annual performance bonus for all positions

34 Paid days off including vacation, sick days & company holidays

Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and other analytical techniques as applicable.

Actively participates in investigation of laboratory results, when required.

Assists, as and when needed, scientists working in the laboratory.

Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.

Performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC as assigned by the supervisor.

SAP or Quality Management System experience

Follow and commit to meet Key Performance Indicators (KPI’s) for safety, quality, production, efficiency, and service requirements.

Develop knowledge of processes, equipment, materials and products.

Six (6) months of experience inspecting and performing quality checks or;

Math skills to include simple addition, subtraction, multiplication and division

Follow practices and processes intended to provide safe products that comply with appropriate laws and regulations, meet the company quality standards.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Responsibilities may include the following and other duties may be assigned.

2+ years of medical device quality experience, with a focus on daily operations and manufacturing quality.

Prior experience providing mentorship to lower level quality engineers.

Experience supporting NPI and production expansion projects.

1- 2 years experience in Quality Management.

Manages equipment acquisition, schedules calibrations, and performs preventative maintenance and equipment qualifications.

Ensures all incoming materials are tested and found to be of acceptable quality before use.

Responsible for assisting in the conduct of internal audits.

Assists in conducting investigations of laboratory deviations and client exceeded concern levels.

Maintains training records and documentation.

1 - 2 years of recent and applicable industry experience, preferably in a pharmaceutical quality control laboratory

Experience with various analytical equipment and methods·

Experience with the application of statistics for data analysis

Experience with computer software (WORD, Excel, etc.)

Experience with aseptic technique and mammalian cell cultures

Experience with inspections, audits, and regulatory agencies/governing bodies.

1-2 years of management experience.

Financial responsibilities and accountabilities include department and capital budgeting and expenditures for areas of responsibility.

Serve as deputy Site Management Representative, as needed.

Excellent command of process validation and risk management for medical device.

Assigns and manages the work of self and direct reports to:

Author, review and implement the quality systems procedures in several sections or departments and manages compliance to the system.

Telephonic Interviews Will Not Be Accepted

Work Site Visits Will Not Be Conducted

Bachelor's degree from a college or university accredited by

Three years full-time, wage-earning parole process, parole officer,

Must have or be able to obtain a certificate of course completion

The salary for an ERS Retiree (or non-contributing member) will

• Education Preferred: Bachelor’s in Engineering or an equivalent discipline.

• Years of Experience Required: 2-3 years

: **Visa sponsorship is not available, now or in the near future, for this position**

Able to prioritize and communicate well with others

Minimum 1 year experience working with Quality Management Systems

Bachelor’s Degree in Engineering, physical sciences or related from an accredited university or college, or equivalent education and experience

Demonstrated ability to work with all levels of employees, management, suppliers and OEMs

Interpret data for senior leadership and manage expectations at all levels

Strong technical aptitude and analytical skills, including engineering tools and systems

Strong interpersonal skills, ability to guide and influence others, and strong team player

Life insurance, short term disability, educational reimbursement, flex spending and employee stock purchase plan

3+ weeks of paid time off plus 10 paid holidays

Medical/dental/vision for employee and dependents at a discounted rate

401K (we match 100% at 6% contribution level)

This position will work in an office setting, expect minimal physical demands.

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Other responsibilities or projects as assigned by reporting manager.

Strong attention to detail and organizational skills

Successful candidate will possess a B.S. Degree in Chemistry, Engineering, or Life Science, minimum of 1 year relevant industry experience preferred.

Experience with analytical technique and instrumentation

Basic knowledge of HPLC/FPLC/GPC systems

Basic knowledge of Karl Fischer Titration

Provide support to QC management, including routine testing

Knowledge and/or hand of experience in Bioassays (CHO), ELISAs, qPCR, and other molecular biology techniques.

Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements

Assist in equipment qualification / validation activities, including maintenance

0-3 years Quality Control experience in a cGMP organization

Demonstrated knowledge of method and equipment

General knowledge of quality management system required

Assist Quality Engineer and management in assessing measures of performance through data collection, reporting and analysis

Work with quality management and support staff to develop solutions to help manage variability

Associate’s degree or equivalent combination of education and relevant experience up to 2 years.

In-depth knowledge of business information systems required

Ability to apply basic problem-solving skills

1-2 years related experience preferred

Knowledge of accounting (construction) principles and controls

Excellent written and verbal communication skills both internally and externally

Ability to evaluate, recommend, plan, and manage projects

Preferred experience in construction job cost accounting

To view additional benefits information for this role, please visit

01 – 02 years related experience required.

Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications.

Responsible for performing process monitoring, labeling control, reinspection process monitoring and sampling process for Reserved Samples.

Provided quality oversight on manufacturing processes to ensure compliance including data integrity.

Provides support for quality investigations and resolution of quality issues.

Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.

Develops detailed, comprehensive and well-structured test cases based on functional and non-functional requirements

Participates in test case reviews and make necessary updates

Builds and uses test data required to accomplish execution of test cases

Executes test cases, including manual and automated tests, and record test results

Reports issues and defects along with appropriate background information for review

Collaborates with developers on reproducing, detailing, and documenting reported defects

Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.

Direct or indirect industry knowledge.

1 year experience preferred in medical device quality, sterility assurance or sterilization operations.

Serves as project lead with projects of intermediate scope and cross-functional teams.

Developing and validating sterilization processes for new and existing products

Qualifying, maintaining, and troubleshooting sterilization of products and associated equipment

§ Certified Quality Engineer (CQE) and Medical device, particularly Orthopedic industry, experience preferred

Ability to deliver, meet deadlines and have results orientation.

Able to communicate both orally and in written form to multiple levels of the company.

Demonstrates characteristics of high potential for future development opportunities.

Formulates procedures, specifications, and standards for Zimmer products and processes.

Develops and implements corrective/preventative action plans.