Job Description
Leading Pharmaceutical Manufacturer Requires Manufacturing Quality Associate Technicians at their Portage Facility! If you meet the qualifications below, APPLY NOW!
Job Summary
The Manufacturing Quality Associate is responsible for ensuring quality and compliance during the day-to-day operations in the manufacturing environment by partnering with operations, supply chain, engineering, quality control, or other functions to support product quality. This role provides GMP oversight through guidance against internal SOPs, WI, Protocols and Records as it pertains to manufacturing activities for development and commercial manufacturing
.
Job Responsibilities
1.Monitors all operations pertaining to manufacturing to ensure adherence to AQST policies and procedures and provides guidance and clarity to colleagues to ensure consistent approaches to product quality are applied.
2.Conducts routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements and to maintain a state of audit readiness.
3. Initiates and investigates nonconformances, project managing to resolve quality issues by partnering with other functions.
4. Author and review Forms, Batch Records, WI, SOPs, Protocols in electronic document management system
5. Investigates assigned product quality complaints utilizing knowledge of the manufacturing and quality processes at this organization.
6. Owns CAPA records and action item implementation, partnering with operations, supply chain, engineering, and QC staff to ensure corrective actions are implemented according to approved timelines and ensuring their effectiveness post-implementation.
7. Coordinates the Environmental Monitoring program including scheduling of third-party water testing, sampling, and report generation.
8. Short to medium term (3-12 months) project owner for quality projects to improve efficiency or compliance profile.
9. Understands the manufacturing schedule and provides quality support to ensure business continuity and seamless transitions between manufacturing stages.
10. Operates with a sense of urgency in a fast-paced environment.
11. Performs real time review of operational records, including Batch Records, and assists in obtaining any required corrections.
12.Performs AQL Testing on finished product by verifying various attributes such as product appearance, product and packaging dimensions, presence, and accuracy of printing on strip and pouch, and seal integrity.
13. Performs line clearances for all steps of the manufacturing process.
14.Reviews, assesses, and archives pest control documents.
15. Maintains QA Retain Program, including sampling, inventory management and inspections required per internal SOPs.
16. Leads process for ensuring manufacturing environment is in a state of control through the evaluation of the building automated system software, in partnership with Maintenance.
17.Determines, documents, and communicates when facility may be released back to cGMP operations after a shutdown, environmental excursion, etc.
18. Performs other duties as instructed by quality management.
19. Acknowledges that this position requires off-hours and weekend work from time to time to assure adequate QA floor support
.
Job Qualifications
1.BS degree preferred preferably in chemistry, biochemistry, or related science field.
2. 5+ years of related experience in the pharmaceutical, biotechnology, or medical device industry responsibility preferred.
3. Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements for the manufacture, testing, and release of pharmaceutical products.
4. Formal training in Quality disciplines (auditing, engineering, process improvement) as demonstrated through certification (ASQ, Lean Six Sigma, etc.) highly preferred.
5. Technical proficiency at reviewing/auditing production records, reports and/or GMP related documentation.
6. Ability to work within a team environment and willingness to contribute to the overall goals of the company.
7. Ability to lead project teams.
8. The ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
9. Good organizational skills, high level of attention to detail, excellent oral and written communication skills with the ability to interact at all levels.
10.Owns a drivers license and can travel between production facilities (<1 Mile) as required.
11. Must be willing to work off hour shifts and weekends as necessary
.
Physical Qualifications
1.Can carry or lift up to 35lbs.
2. Be able to pass vision and hearing testing as required.
3. Can spend up to 50% of the shift working while standing or moving.
...employee engagement that ultimately results in a higher level of service, they are looking to hire a Human Resources Manager . This individual will be responsible for... ...a vast network of high-quality candidates from entry to executive-level experience. Our areas of...
Sports & Social is a one-of-a-kind sports bar, gaming parlor, and social lounge in Atlanta. This two-level space features a 30-foot diagonal... .../food handler card as required by local or state government agency. May be required to work nights, weekends, and/or holidays....
Looking for spine distributors with existing physician relationships. Company has a portfolio of spine products covering minimally invasive... ...in spine. Very aggressive commission plan. Nationwide opportunity Employment Type: Contractor Salary: $ 100,000.00 Per Year
Operations Partner, Burger King, US Southeast Ready to make your next big professional move? Join us on our journey to achieve our big dream of building the most loved restaurant brands in the world.Restaurant Brands International Inc. is one of the world's largest quick...
...Norwell, MA 02061 Department Name SMC Urgent Care Status Full time Budgeted Hours... ..., documents findings, and writes medical orders and or prescriptions. Makes clinical... ...Education - Completion of Advanced Physician Assistant or Nurse Practitioner training program...